Medical Devices Regulatory and V&V Services

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 bring the most suitable and high quality resolutions for our clients.

Our services are provided for all types of medical devices, including In-Vitro Diagnostics (IVD), Combination products and Digital health.

The 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 of medical devices for R&D processes including the implementation of suitable standards and testing, product verification and validation activities and more
  • Supporting Verification and Validation activities (V&V) of medical devices including, Biocompatibility, Biological evaluation, Chemical characterization, Cleaning validation, Re-processing validation, Packaging and shelf-life validation, Sterilization validation, Usability and more  
  • Pre-clinical and Clinical services for medical devices, such as Clinical evaluation (CER, BER), Clinical investigation/ Clinical studies/ Clinical trials/ Clinical monitoring, Investigator Brochures, Informed Consents 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), Vigilance.
At its heart, engineering is about using science to find creative, practical solutions. It’s a noble profession.
Queen Elizabeth II
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