Regulations change from region to region. Stay compliant as you grow with a dedicated regulation intelligence team.
Launching or sustaining a medical device or IVD (in vitro diagnostic) product can be a long and complicated process, even when regulatory requirements are known, because global regulations are constantly changing to ensure patient safety. To comply with medical device regulations, manufacturers need structured, well-managed approaches tailored to their product portfolios for each geography.
Wipro has extensive knowledge of global medical device regulations and compliance obligations for medical device manufacturers (FDA, EU MDR, EU IVDR, MHRA, ANVISA, Health Canada, Pharmaceuticals and Medical Devices Agency, TGA, National Medical Products Administration, CDSCO etc.). Our dedicated intelligence teams are fluent in all relevant technical standards and guidelines (ISO, IEC, ANSI, NIST, ASTM, IEEE, IMDRF, FCC, CLSI), and continuously monitor intelligence to ensure we remain up to date on changes across countries.
Our regulatory consulting services accelerate time to market with strategic launches that avoid unnecessary penalties for non-compliance.
- CE marking (EU MDR, EU IVDR)
- Impact assessment, remediation, and maintenance of regulatory files
Design history file, technical file, design dossier
- 510 (k) and PMA preparation
- RIMS document management
- International regulatory audit support and vigilance reporting (MDR, MIR)
- Health inquiry support
- Local authority submissions