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.
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
●Software as Medical Device (SaMD)
●Clinical Decision Support (CDS)
●Software in Medical Device (SiMD)
●IVD – In Vitro Diagnostics
●MMA – Mobile Medical Application
learn more about our CRO services at the following link:
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.
Navigate your product development towards market compliance
●HIPAA and relevant FDA, including the “Center of Excellence” guidance
●Competent Authority and Notified Bodies (NB)