Expanding Medical Device Markets Beyond Canada and the US

Useful Resources

• Best Practice Guidance for the Submission of Technical Documentation under MDR (PDF)
• IMNB AB & IMNB UK Ltd Declaration of Impartiality 2023 -2024 (PDF)
• European Commission - Medical Devices (health.ec.europa.eu)
• Intertek Medical Notified Body Standard Fees (PDF)

• ISO 13485 - Quality Management Systems for Medical Devices
• The EU Medical Devices Regulation (MDR 2017/745)
• ISO 22716 – Good Manufacturing Practices for Cosmetics
• Medical Devices Directive 93/42/EEC
• Indian Certification of Medical Devices Scheme (ICMED)

• MDSAP - Medical Device Single Audit Program
• The EU Medical Devices Regulation (MDR 2017/745)
• ISO 22716 – Good Manufacturing Practices for Cosmetics
• Indian Certification of Medical Devices Scheme (ICMED)
• Medical Devices Directive 93/42/EEC