Digital Health
The Digital health revolution is already here. the development of groundbreaking technologies together with the COVID-19 pandemic gives rise to many digital health solutions. The vision of the digital health strategy as published by the Israeli Ministry of Health (MOH) is to “enable a leap in the healthcare system so that it will be a sustainable, advanced, innovative, renewable and constantly improving the health system, by leveraging the best available information and communication technologies”. As for any medical product, digital health products must obtain specific regulations in order to bring their product from concept to reality without compromising on safety and efficacy. With years of experience in the field of medical devices, Gsap provides quality, regulation, validation, and clinical services for the digital health industry in order to bring the product in the shortest time and maximum quality to the patient.
Quality
Our Quality services include:
●Writing quality procedures for design and development according to ISO 62304
●Processes for privacy, information security, and cyber security according to HIPPA, GDPR, ISO 27001, ISO 27799
●Risk management according to ISO 62304, IEC 60601-1
●General safety and Usability according to IEC 62366-1
Regulatory
●Software as Medical Device (SaMD)
●Clinical Decision Support (CDS)
●Software in Medical Device (SiMD)
●IVD – In Vitro Diagnostics
●MMA – Mobile Medical Application
Clinical
learn more about our CRO services at the following link:
CSV
Our CSV services comply with the updated concurrent regulatory requirements and guidance e.g., 21 CFR Part 11, Part 820, GPSV, GAMP RDI & MHRA for data integrity, ISO 13485, IEC 62304, GAMP5, EU GMP Annex 11.
●Computerized System Validation services for pharmaceutical and medical device companies.
Global submission
Navigate your product development towards market compliance
USA
FDA
Regulations:
●21CFR820
●HIPAA and relevant FDA, including the “Center of Excellence” guidanceEurope
Europe
●Competent Authority and Notified Bodies (NB)
●GDPRIsrael
MOH
APPLICABLE STANDARDS
Customers
NEWS & ARTICLES
OUR CUSTOMERS SAY
Collaborating with Gsap is always a pleasure. Gsap representatives are highly professional, very focused and results driven. Each project when working with Gsap was clearly defined, timed and executed and most importantly achieved the main goal of having our products registered on time for marketing. Gsap supplies the most wholesome solutions for a variety of projects in both regulatory and quality aspects and on a personal level, people are really nice and fun to work with. Thank you Gsap, can't wait for our next project.
Nirit Blayer
VP Regulation and Quality at 6over6 Vision Ltd