We are happy to share our range of services that we are providing to the digital health community to accelerate and promote startups- from concept stage to product approval.
You can find us also in the digital edition of” digital health” magazine in the “HAARETZ” newspaper:
The Digital Health Revolution is happening all around us and it is both exciting and terrifying. As a member of the Medical Device community, we have a responsibility to our patients, our families and our shareholders to follow the current best practices. To date, the standards and regulations have not been able to keep pace with the needs of the patients and the industry that satisfies these patient and user needs.
Topics in this newsletter:
Many regulatory agencies including the FDA are talking about forming committees that will codify the “current best practice”, often referred to as GxP or “Good [insert name] Practice”. In January 2020, the FDA released a discussion paper titled US FDA Artificial Intelligence and Machine Learning Discussion Paper, in this paper the agency proposes a framework for Good Machine Learning Practices and below is a visual representation of the GMLP workflow.
In addition, to address the critical question of when a continuously learning AI/ML SaMD may require a premarket submission for an algorithm change, this discussion paper proposes a framework for modifications to AI/ML-based SaMD.
To date, the FDA has cleared or approved several AI/ML-based SaMD however these have only included algorithms that are “locked”. The power of many of these AI/ML-based SaMD lies within the ability to continuously learn, where the adaptation or change to the algorithm is realized after the SaMD is distributed for use and has “learned” from real-world experience. Following the distribution, these types of continuously learning and adaptive AI/ML algorithms may provide a different output in comparison to the output initially cleared for a given set of inputs.
To adapt to this, the FDA is proposing a principle of a “predetermined change control plan.” The predetermined change control plan would include the types of anticipated modifications based on the retraining and model updating strategy, and the associated methodology – referred to as the Algorithm Change Protocol (ACP) – to be used to implement those changes in a controlled manner that manages risks to patients, see below for an outline of the main components of an ACP:
The result is a modification to the current guidance for software Deciding When to Submit a 510(k) for a Software Change to an Existing Device | FDA . See below for a proposal to the current guidance
Back in July 2020, the FDA released a Final Guidance Document looking at what happens when the same medical product has both functions covered by the FDA and functions not covered by the FDA. The uniquely unclear guidance titled Multiple Function Device Products: Policy and Considerations looks at what happens when a single product with multiple functions have some that are “regulated” and require FDA review, clearance or approval other functions that do not require FDA involvement (other regulations like FCC or CE standards for electronics, RoHS, WEEE, UL and other TLA’s may be required).
A “function” is a distinct purpose of the product, which could be the intended use, or a subset of the intended use of the product. A product with an intended use is to store, transfer, and analyze data has three functions: (1) storage, (2) transfer, and (3) analysis.
While storage & transfer may not be considered requiring regulatory oversight, the addition of analysis and the type of analysis may require FDA involvement. To make things even more complicated, the FDA has issued guidance that indicates while not “fully ok” the FDA does not intend to focus its regulatory oversight on some devices that pose a low risk to patients for more on this ever growing category see the FDA’s guidance “Policy for Device Software Functions and Mobile Medical Applications” and “General Wellness: Policy for Low Risk Devices.”
Many CEO’s will attempt to push themselves into this “low risk category”, as with most things, the agency has discretion, but with software being the leading cause of recalls in the US, the FDA will be waiting to investigate any complaints and will be looking to punish those that have not followed the guidelines to the agencies liking.
So how do we determine if the “non-FDA-regulated” or as the FDA likes to call it the “other function” impacts on the “regulated” feature?
Start with 2 questions, and answer them as if you were working for the FDA:
1) Is there an impact on the safety or effectiveness of the “regulated” feature as a result of the “other function?”
if yes,
2) Could the impact result in increased risk or have an adverse effect on performance of the device function-under-review.
I would very much like to say that from the FDAs perspective the following is true:
However, there are always exceptions and those edge cases is why we sometimes need to speak with a member of the Gsap digital health team Regulatory Review Team to confirm.
Below are a number of relevant examples from the guidance for your consideration, while some may enlighten, others may confuse, but that is the art of regulatory science.
This Newsletter Prepared by:
Yaron Eshel, Q&R project manager
Medical device, Digital Health Discussion Team
How Gsap experts accelerate Healthcare companies during COVID-19 pandemic?
Interview with Our CEO Dr. Sigalit Ariely-Portnoy
Read more at: https://www.haaretz.co.il/st/inter/Global/magazine/Haaretz/2020/12%20Dec/hitech/index.html#p=50
The Nobel Prize for Chemistry was awarded this year for the invention of Genetic Scissors: a tool for rewriting the code of life.
Emmanuelle Charpentier and Jennifer A. Doudna have discovered one of gene technology’s sharpest tools: the CRISPR/Cas9 genetic scissors. Using these, the DNA of animals, plants and microorganisms can be changed/edited with extremely high precision.
This technology has had a revolutionary impact on the life sciences, is contributing to new cancer therapies and may make the dream of curing inherited diseases come true.
Since the discovery of CRISPR/Cas9, the research of this tool has led to a blooming landscape of pre-clinical and clinical studies in humans.
FDA considers any use of CRISPR/Cas9 gene editing in humans to be gene therapy, thus requiring extensive regulatory efforts in order to bring such products from early concept to clinical application.
Gene therapy products are regulated by the FDA’s Center for Biologics Evaluation and Research (CBER). Clinical studies of gene therapy in humans require the submission of an investigational new drug application (IND) prior to their initiation in the United States, and marketing of a gene therapy product requires submission and approval of a biologics license application (BLA).
At Gsap, our team of Advanced Therapies experts is excited to be at the frontier of this field, with a unique portfolio of process development, preclinical, clinical and regulatory services, assisting our clients to bring gene-therapy products from early POC to realization into clinical use.
If you develop a gene-editing product, do not hesitate to contact us!
This Newsletter Prepared by:
Diana Gershtein, M.Sc., M.B.A.
Cell Therapy Section Manager
Dr. Sigalit Arieli Portnoy, CEO and Founder of Gsap, talks in an exclusive interview about accelerating the development and approval processes of drugs and medical equipment for COVID, including from foreign companies, and reports On the enormous scope of action that accompanies a sense of mission.
What needs to be reviewed?
Where to Start?
What to do?
1. Classification – This will lead to updating the Declaration of Conformity.
2. GSPR – any gaps identified (validations or issues that have not been reviewed in the past) must be closed. *** See table below for an example of the GSPR vs. the Essential requirements
3. PMS (Post Marketing Surveillance), PMCF (Post Marketing Clinical Follow Up) – start the implementation of the plan as soon as possible and write a summary report of all data collected to date.
4. Risk Management – verify that hazards have been identified and that the clinical risks have been mitigated.
5. Any Biocompatibility testing that has not been done and cannot be rationalized should be performed.
6. Make sure your QMS adheres to the requirements of the MDR – the following requirements are unique to the MDR:
Example of the GSPR vs. the Essential requirements
| Wording GSPR (MDR) | Wording Essential Requirements (MDD) | Explanation of the Gap |
| That the residual risk associated with each hazard as well as the overall residual risk is judged acceptable. In selecting the most appropriate solutions, manufacturers shall, in the following order of priority: 4(a)Eliminate or reduce risks as far as possible through safe design and manufacture 4(b) Where appropriate, take adequate protection measures, including alarms if necessary, in relation to risks that cannot be eliminated 4(c) Provide information for safety (warnings/precautions/ contraindications) and, where appropriate, training to users.” | Information needed to use the device safely.” Within the framework of labeling | Management would need to be “information for safe use” with the quote and where this information is supplied and a usability study to support the information for safe use is valid. |
| “11. Infection and microbial contamination 11.2 Where necessary devices shall be designed to facilitate their safe cleaning, disinfection, and/or re-sterilization” | 13. Information Supplied by the Manufacturer h) if the device is reusable, information on the appropriate processes to allow reuse, including cleaning, disinfection, packaging and, where appropriate, the method of sterilization of the device to be reserialized, and any restriction on the number of reuses.” | The MDR has defined a particular consideration for reusable devices, meaning a clearly stated requirement that must be validated. The MDD does not clearly state a validation requirement for reusable devices, only the requirement to supply the information to ensure safety. |
| “14.1 If the device is intended for use in combination with other devices or equipment the whole combination, including the connection system shall be safe and shall not impair the specified performance of the devices. Any restrictions on use applying to such combinations shall be indicated on the label and/or in the instructions for use. Connections which the user has to handle, such as fluid, gas transfer, electrical or mechanical coupling, shall be designed and constructed in such a way as to minimize all possible risks, such as misconnection.” | “9.1 If the device is intended for use in combination with other devices or equipment, the whole combination, including the connection system must be safe and must not impair the specified performance of the devices. Any restrictions on use must be indicated on the label or in the instruction for use.” | The MDR has added an additional requirement regarding connections that are user dependent for combination devices. |
| “15. Devices with a diagnostic or measuring function” | 10. Devices with a measuring function” | The inclusion of diagnostic devices within the requirements of a measuring function is new to the MDR, emphasizing the need for validation of measuring functions in diagnostic devices. |
| “17.2 For devices that incorporate software or for software that are devices in themselves, the software shall be developed and manufactured in accordance with the state of the art taking into account the principles of development life cycle, risk management, including information security, verification and validation.” | “12.1a For devices which incorporate software or which are medical Software in themselves, the software must be validated according to state of the art taking into account the principles of development lifecycle, risk management, validation and verification.” | The MDR has set design and development requirements for software. This means that the D&D software process must be managed by means of documented inputs, outputs, risk assessments, verifications and validations |
Gsap will be happy to support you in getting ready for the MDR storm!
This Newsletter Prepared by:
Ossie Milanov, BA
Quality & Regulatory Project Manager
All companies aim to have high quality products and services, it is the rare few that actually achieve this desirable goal. The way to achieve this goal is by asking and answering 3 questions:
This newsletter gives you practical tools for answering these 3 questions and demonstrates how Gsap can help you to establish a culture for quality, manufacture quality products and have a sustainable, efficient and effective quality system.
A major survey, conducted by CEB (Corporate Executive Board Company) in 2013 under the topic “Culture of Quality Benchmarking survey”, used the following tool to estimate the culture for quality in In hundreds of organizations.
Gsap can help you implement this simple tool in your organization:
Step 1 – Data collection:
Ask employees in the organization to specify for each of the following 4 statements, whether they agree or disagree with the following statements.
Present the data in the following table and calculate the scores:
Step 2 – Benchmark and Criteria:
Compare your scores with the score received in the CEB survey for companies with high quality / culture for quality.
In those companies the following results were received:
| I hear quality | 90-100% |
| I see quality | 90-100% |
| I feel quality | 45-80% |
| I transfer quality | 90-100% |
Step 3 – Data analysis and actions to be taken:
If you find that your company is in the 3rd quintile or lower, it is time to define some steps to improve the situation. We, at Gsap, can help you do that by identifying the root causes and building together with you a strategy for change. Some of the root causes for low culture for quality may be:
■ Failure to implement company values from top management to each and every employee
■ Failure to maintain consistent leadership emphasis and help leaders recognize where their actions contradict stated quality policies and objectives.
■ Failure to ensure that quality messages are credible and relevant. For diverse
organizations that operate in multiple geographies, this means finding a way to tailor messages without ceding control, and being globally consistent yet locally relevant.
■ Failure to demonstrate peer prioritization of quality by generating a social climate that encourages employees to support each other in generating quality ideas, without this effort appearing to be pushed from the top down.
■ Failure to build employee ownership through targeted guidance, setting forth enough guidance to give employees confidence to act, yet not so much that independent decision making is stifled.
In 2011 the FDA published their initiative for “Case for Quality”, saying that “Compliance to regulations is not enough…
The goal for the case of quality is to afford patient access to high quality medical devices”
The aim of this initiative was to arm industry with practical metrics to implement that meet both the business needs and the product needs, so that the Right-First-Time mentality from the initial day of development will return as much as possible.
The FDA defined matrixes in 3 major areas.
Our quality experts in Gsap, can help you establish these matrixes, properly collect the data, analyze the results and set actions for improvement.
Following are some effective Implementation principles
Pre-Production Metric:
Total # of changes (product & process across projects)
________________________________________________________
Total # of projects
Goal:
To drive the Right-First-Time (RFT) mindset in the R&D phase such that post-design transfer changes (after design freeze) due to inadequate product /process development are not needed.
Calculation:
►Only include changes required due to inadequate product or process development
► Harmonize definition of “changes” across organization and classify the significance of varying levels of changes based on risk.
► Determine what constitutes a project (“project” encompasses all aspect of the product being transferred to production).
► Ideal to measure the changes required during: (1) Design transfer (after design freeze), (2) Production, (3) On-market
Production Metric
Total # of units manufactured right first time (within or across lots)
__________________________________________________________
Total # of units started
Goal:
To gather nonconformance information during production operations related to inadequate product/process development.
Analysis of this information will enable to assess the effectiveness of the development process and improve it.
Calculation:
►Include all non-conformances initially (to get a first past yield) & Scrapes
►Triage the root causes
►Track and trend on a rolling basis
►Ensure terms are defined consistently across products and sites
►Raw materials/component failures are not to be included.
Post-Production Metric
Here we have several matrices:
(3) Unplanned Service Records (% out of total units in service)
(4) Installation failures (% out of total installations)
(5) Complaints (% out of total units sold, including non-safety complaints)
(6) MDRs (% of units with “Medical device reporting”, out of total units sold)
(7) Recalls (% of products that had to be recalled, out of total units sold)
Calculation & Analysis
►Step 1: Calculate and track
each of the post-production metrics. Identify trends, and have predetermined action limits.
►Step 2: Use advanced calculations to incorporate product risk profile information into the calculation of each indicator (see table below).
►Step 3: Use comparative analyses to conduct through mechanisms such as dashboard.
Finally:
You can incorporate pre-production & production metrics with post-production.
This can give you an enterprise-wide view of the risk to product quality
An effective QMS is a QMS that achieves its goals and objectives. But, in order to have a sustainable quality culture, being effective is not enough – we also need to be efficient.
Having an efficient QMS means a system that meets the company’s needs. A smart and “thin” and agile system where you have zero unnecessary bureaucracy
Gsap quality experts can help you to build the QMS that is right for you!
Our quality services include the following:
| Culture for quality | Building a culture for quality, based on company values and substantial quality metrics | |
| QMS procedures | writing procedures that are suitable for your company | |
| Document and Record controls | building DHF, DMR, DHR etc. | |
| QMS improvements | management of CAPA, NC, complaints, etc. | |
| Quality Training | training for all elements of the QMS, including training for employees, quality engineers, Q&R managers and for management. | |
| Quality Audits | internal audits, supplier audits and audits by MDSAP | |
| e-QMS | implementation of a full QMS on an electronic platform | |
| Total quality management services | Gsap Q&R expert can help you to manage your quality and regulatory activities, including providing guidance to your PRRC (person responsible for regulatory compliance) | |
| Design controls | building the right flow and steps for full design controls, from concept to getting your regulatory approvals and marketing | |
| Risk management | implementing risk management procedure according to applicable regulations and standards (such as ISO 14971:2019 and ISO 24971:2020) including incorporation of usability risks and other related risks, using applicable tools such as FMEA and FTA | |
| Supplier controls | evaluation and selection of suppliers and on-going supplier control. | |
| Production controls | environmental controls, equipment qualification (IQ, OQ, PQ), process validation, measuring devices controls including TMV (test method validation) | |
| Statistical techniques | including statistical acceptance sampling (based on international standards), statistical process control (SPC), evaluation of process capabilities (such as Cpk and Ppk) determination of sample size for product verification, product validation and process validation | |
| Preparations for 3rd party audits | Gsap Q&R experts are certified as lead auditors and can help you to be prepared for 3rd party quality audits from regulatory authorities to due-diligence |
Gsap experts are here for you, to help you establish a culture for quality, build quality products and have a sustainable, efficient and effective quality system!
This Newsletter Prepared by:
Marina Lebel, B.Sc, CQE
VP Medical Device
Learn how to implement EU GMP standarts in medical cannabis.The EU GMP presents the requirements for facility, equipment, documentation and process control for production of herbal products.
The FDA takes steps to promote faster access to new medical technologies that are safe and effective: Streamlining premarket procedures, modernizing the 510(k) program, expediting programs for devices that enhance safety and/or resolve critical unanswered medical needs. The recently issued guides include: new pathways, expansion of existing programs, and supporting tools such as checklists and assessment worksheets.
Topics in this Newsletter
510(k) Programs
1. Special 510(k) (UPDATED)
2. Abbreviated 510(k) (EDITED CONTENT)
3. Safety & Performance Based Pathway (NEW)
Additional Premarket Programs
4. Humanitarian Device Exempt (HDE) Program (UPDATED)
5. Safer Technology Program (STeP) (NEW)
More FDA Actions
6. Electronic submissions;
7. Benefit-risk determinations;
8. Acceptance review policy (RTA);
9. Accreditation of testing labs (ASCA)
Adapting the repeatedly-criticized 510(k) program to advances in safety and technology; providing clearer requirements and more timely review & response, and lowering workload for FDA and costs for the industry.
Let’s take a short tour to some of the ideas and changes that these documents bring about.
What’s new with the 510(k) program?
The 510(k) program accounts for the vast majority of devices that enter the market each year. It is based on the concept of “substantial equivalence”. The FDA now issues final guidance documents for the Special 510(k) Program, the Abbreviated 510(k) Program, and the Safety and Performance Based Pathway, as well as a Format for Traditional and Abbreviated 510(k)s.
1. The special 510(k) program
This program is Intended specifically for changes of own existing device, and only if the methods to evaluate changes are considered well established. FDA reviews special 510(k) applications within 30 days of submission. This final guidance expands the scope of the program.
The significant changes in the program:
• Now, under certain circumstances, changes to the intended use may be made.
• Now, under certain circumstances, changes that alter the fundamental scientific technology may be made.
• If performance data is necessary, it is required that methods are well established and that all data supporting substantial equivalence can be reviewed in a summary or risk analysis format.
NOTE: This pathway therefore may NOT be appropriate,
for example, when a novel sterilization method is used; or methods rely on animal/clinical data; or the changes are complex – with many scientific disciplines involved, change from single-use to re-usable, etc. – so that determining the substantial equivalence depends on the FDA’s interpretation of the underlying data.
2. The abbreviated 510(k) program
An alternative approach to the traditional 510(k): Instead of performing a “head-to-head” comparison with a predicate device in order to demonstrate the substantial equivalence, you declare conformity to voluntary consensus standards / special controls / FDA guidance.
This program is NOT new, but merely received a guidance document separate from the special 510(k) program. It includes a short outline of the content required.
NOTE: This pathway is not necessarily “abbreviated” or shorter.
Also, the review time is 90 days, as for the traditional 510(k). However, under some circumstances, when it is difficult to collect data regarding a predicate, it might be more efficient to submit summary reports describing how reference standards were used or how the device complies with the special controls. Addressing the FDA early to find out which pathway is appropriate, would be a good idea.
3. Safety and Performance Based Pathway
An optional submission pathway, extension of the abbreviated program. It is intended for well-understood devices, listed by device type, for which the manufacturer would to have meet objective criteria set by the FDA: criteria that would be consistent with safety and performance characteristics of modern predicates. Along with the guidance describing the general pathway, five additional draft guidance documents were issued, describing the required performance criteria for specific devices:
Foley catheters
Recording cutaneous electrodes 03Ø06
Orthopaedic spinal plating systems
Non-spinal screws & washers
Magnetic resonance (MR) coils
The basics you should know about this pathway:
• It’s not actually different from the abbreviated 510(k).
• The requirements may be more specific, thus clearer to the
manufacturer (that’s a bonus).
• May be suitable when attaining information regarding an
actual predicate is impossible/impractical.
Additional programs and pathways at focus :
4. The Humanitarian Device Exemption (HDE) Program
HDE program receives an updated final guidance, accompanied by the newly revised guidance for Humanitarian Use Device (HUD) Designations. Both follow changes resulting from the “Cures Act”.
The purpose of this program is to encourage development of devices for diagnosis and treatment of rare medical conditions.
The main updates:
• Expansion of the HUD designation: The designation is given when the relevant population is up to 8000 individuals per year in the USA, instead of the previous threshold of less than 4000.
• A device may still receive HUD designation in the pediatric population even when total condition population exceeds 8000 patients, if the pediatric population affected does not exceed 8000 patients.
• For diagnostic devices, the threshold applies to not more than 8000 who would be subjected to the diagnosis with the device, including positive and negative results.
• As was before, in order to make use of an approved HUD in patients, oversight of an Institutional Review Board (IRB) in the medical facility is required, and review and approval for the specific individual use is also required. This was previously also required to be performed by the IRB. Now more flexibility is introduced, as an appropriate local committee (ALC), that may be a standing committee with the appropriate expertise, is allowed to review and approve the specific HDE use, and not only the IRB, which may be considered less accessible. IRB facility overview is still required.
• A filing checklist, and tools for the probable benefit-risk assessment are included in the appendices.
5. Safer Technology Program for Medical Devices (STeP)
More action in promoting patient safety:
The draft guidance for this new voluntary program is issued
– complementary to the “Breakthrough Device Program” (BDP), for medical devices that are expected to significantly improve the safety of currently available treatments.
Devices and device-led combination products, that are subject to review under 510(k), De Novo or Premarket Approval (PMA) submissions, and that are not eligible for the BDP, may enjoy the expedited STeP approach:
• First apply through a Q-submission (pre-sub) to be included in the program;
• Once accepted, go through prioritized and expedited review of regulatory submissions, with senior FDA management engagement, and assistance with the plan of device and data development.
To apply, the sponsor should explain the innovative approach and how the benefit-risk profile would be improved:
• Does the device reduce the occurrence of a known serious adverse event / device failure mode / user-related hazard or error?
• Does the device improve the safety of another device or intervention?
NOTE: The Breakthrough program which is intended for lifethreatening
/ irreversibly debilitating conditions, is mandated by law and would still be prioritized over STeP. This is expressed in the draft with the repeating phrase: “as resources permit”.
Thus, only time will tell if STeP achieves its purpose to open an actual additional expedited pathway.
More FDA actions to streamline, simplify, expedite, clarify…
6. The FDA goes paperless – electronic submissions are on the way
Following requirements of the FD&C Act, a draft guidance regarding electronic submissions was issued. But don’t get rid of your printers just yet – it will take a little while.
The guidance tells us that:
• Application types that would be required to be submitted solely in an electronic format, include 510(k), PMA, De
Novo, Investigational Device Exemption (IDE), HDE and more.
• Individual, per-type guidance documents will be developed, specifying required formats and implementation timetable.
• IDE compassionate use requests and adverse event reports will be exempt from this requirement.
ATTENTION: In contrast to most guidance documents, which contain nonbinding provisions, this guidance and the following
individual ones – once finalized, will contain both nonbinding AND binding provisions under statutory authorization of the Congress: I.e., sponsors will be required by law to comply with the specified formats & schedules.
7. Clarifying benefit-risk considerations for higher-risk submissions
Two final guides were issued (1, 2), both actually discuss the same subject: determining uncertainty and benefit-risk in PMA, HDE, De Novo and BDP submissions.
Some key concepts:
• Greater uncertainty may be accepted when there’s a true clinical need: serious / unanswered / small patient population / high anticipated benefit for quick patient access.
• Higher uncertainty greater need for premarket data; Lower uncertainty data shift to post-market may be allowed.
• Post-market data is always required. It is critical to show that it can be collected in a timely manner, especially as risk/ uncertainty increases.
• A new worksheet is provided as appendix; Recommended as a basis for the benefit-risk assessment process.
• FDA wants patient perspectives – are the patients really willing to accept the risk and the uncertainty?
8. Saving time for FDA reviewers and for sponsors
– acceptance review policy
Final updated “Refuse to Accept” (RTA) guidance was issued for 510(k) and for De Novo submissions. These outline the preliminary procedure the FDA performs to assure administrative completeness of submissions (including timetable), which takes place before the substantive review that assesses the quality of the information.
Some highlights:
• A checklist of required criteria is provided for each submission type (in the appendices).
• FDA will, within 15 days of submission, electronically notify the submitter if: (a) submission was accepted and under substantive review;
(b) submission was refused PLUS indication of the missing checklist items, or;
(c) FDA did not complete acceptance review on time, thus transferred
submission to substantive review.
• This notification identifies the lead FDA reviewer assigned for the submission.
• The De Novo guidance includes a recommended content checklist as well, relevant also for the substantive review.
• RECOMMENDED: Follow the checklist, complete it, and include it as part of the application. Do NOT leave sections out (if not applicable – state so & justify). Letters from subject matter experts are helpful.
9. Accelerating review processes by accrediting testing labs to FDA-recognized standards
Draft guidance for The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program was issued.
OBJECTIVE: Streamline reviews – once a manufacturer presents results from an accredited body, FDA can accept them without a thorough review. Pilot begins with standards for biological evaluation and for electric safety.
Gsap experts will be happy to assist you in choosing the regulatory track that!
suits your product and company, and to support you in the submission process.
This Newsletter Prepared by:
Orly Chillag – Talmor, Ph.D.
Quality & Regulatory Project Coordinator
