Medical Devices

    Medical Devices

    Medical devices industry Gsap

    In the spirit of Gsap’s vision, the medical device section aims to bring safe, high quality products to patients in the shortest time possible

    Medical Devices LIFE CYCLE

    We are your partner from idea to market compliance!

    Planning of Product realization

    Planning of Product realization-medical d
    • Product classification
    • Regulatory strategy
    • Clinical strategy

    Design & Development

    • Quality plan and design input
    • Design output
    • Validation and verification
    • Preclinical and clinical trials

    Marketing

    • Regulatory submission clearance & approval
    • Transfer to production
    • Post market activities
    fda approved

    Regulatory and V&V

    Gsap provides extensive regulatory support from regulatory strategy development and submission to surveillance audits and liaison with FDA, Notified Bodies and other Competent Authorities. We work thoroughly and vigorously, incorporating a balanced business approach, to provide the most suitable and high-quality solutions for our clients.

    Our regulatory services include:

    ●Regulatory strategy & Regulatory plan including classification of medical devices (USA, EU, Israel, Canada, Australia, Brazil, Japan, WHO and other markets).

    Consultation with medical devices regulatory authorities (FDA, Notified Bodies-NB, Competent Authorities-CA, AMAR).

    Registration of medical devices including UDI and labeling (Class I, Class IIa, Class IIb, Class III, Class A, Class B, Class C, Class D).

    Planning, Writing and Review of Submissions and technical files of medical devices for FDA-510(k), FDA-De-Novo, FDA-PMA, EU-CE mark, Health Canada, AMAR, Canada, Australia, Brazil, Japan and others.

    Product-related regulatory support and technical guidance for medical devices R&D processes including the implementation of suitable standards and testing, product Verification and Validation (V&V) activities and more.

    ●Supporting multifaceted V&V activities for medical devices including, Biocompatibility, Biological evaluation, Chemical characterization, Cleaning validation, Re-processing validation, Packaging and shelf-life validation, Sterilization validation, Usability and more.

    ●Implementation and periodic review of regulations, standards and guidelines for medical devices (EU-MDD, EU-MDR, EU-IVD, EU-IVDR, 21CFR820, MDSAP, GMP, ISO13485, ISO14971, ISO10993, ISO14698, ISO14644, ISO14155, ISO11607, ISO60601, ISO62366, ISO11135, ISO11137, ISO17025, ISO15189).

    Implementation of the new European regulation for medical devices (EU-MDR 217/745) including update of essential requirements to GSPR (General safety and performance requirements), EUDAMED, PMS (Post marketing surveillance), PSUR (Periodic safety update report), PMCF (Post marketing clinical follow up) and Vigilance.

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    Quality(QMS)

    Gsap establishes a culture for quality and improves quality system management (QMS). We develop, together with the client, a quality system that suits the organization and the product, both for clinical care and commercial applications, including all aspects required during the medical device life-cycle.

    We identify the requirements defined by regulatory authorities and international standards applicable to the specific medical device.

    Our Quality services include:

    ●Risk management (including dFMEA and pFMEA)

    Product design & development

    Product verification and validation (V&V)

    Purchasing controls and acceptance sampling inspection

    Transfer to production

    ●Production & service control, including process capability control

    Process Verification and Validation

    ●Control of measuring equipment

    ●Production, labeling, packaging, distribution

    ●Quality management reviews

    ●Non-conforming product (NC)

    ●Complaint handling

    ●Corrective and Preventive Action (CAPA)

    ●PMS (Post marketing surveillance)

    ●PMCF (Post marketing clinical follow-up)

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    Clinical

    With a high level of expertise in clinical affairs, we support clinical trials for Class I, II and III medical devices, leading to high quality clinical data as per ISO14155 and ICH-GCP.

    We offer clinical strategy development, medical writing, submissions and clinical trial initiation, execution and monitoring, data management, auditing, training and project management.

    Process Validation

    The engineers in Gsap offer an efficient and systematic approach based on risk assessment for facility and plant design, building and renovating facilities as well as project validation.

    We use our scientific and process knowledge, production experience and pragmatic approach to protocol writing and execution.

    Our Validation services include:

    GMP consultants for plant design 

    ●Validation Project Management

    ●Validation of facilities, critical systems and equipment

    ●Process and Cleaning validation

    ●Characterization of technical / engineering aspects of equipment and systems

    FDA audit

    Audits

    Quality audits are required by medical device standards and regulations. Quality audits, when conducted in a professional manner, can have a great added value.

    Gsap provides a wide range of Internal and External audits and Site auditing. These audits are a necessary quality tool for meeting GMP requirements and authorizing suppliers, as well as for preparation for audits of the regulatory authorities (FDA, ISO and more).

    Our Audits services include:

    Internal audits:

    Internal quality audits for evaluation of the QMS in accordance with ISO 9001

    Internal quality audits for evaluation of the QMS in accordance with ISO 13485

    Internal quality audits for evaluation of the QMS in accordance with MDSAP

    External audits:

    FDA mock audit

    Preparation for CE audits

    Custom-made audits according to customer’s request

    Global Submission

    Navigate your product development towards market compliance

    • USA

      FDA

      Approval process:

      ●Registration
      ●510(k)
      ●PMA
      ●De-Novo

      Our services include registration, writing pre-submission and submission files, communication with the FDA and preparation for FDA audits as necessary.

    • Europe

      CE

      Gsap can help you to get your CE mark in Europe. Our services include writing and implementing QMS procedures, writing the technical documentation and preparing for the notified body’s audit.

    • ISRAEL

      AMAR (MOH)

      Gsap can help you to get your approval in Israel. This includes preparation of the necessary documentation and communication with AMAR in the Israeli Ministry of Health (MOH).