Medical device regulatory requirements are very detailed and require the appropriate diligence before a medical device can go to market

Aptiv Solutions is a full-service CRO, which has helped hundreds of medical device and diagnostics innovators to navigate the challenging journey from product concept to commercialization.

Our medical device regulatory experts often refer to the following documents for medical device FDA guidance and for guidance in meeting Medical Device Directive (MDD) requirements and Canadian Medical Device Regulations.

Contact ICON today for help in meeting these complex medical device regulatory requirements.

FDA Medical Device Regulatory Guidance

510k FDA Guidance Documents and Memos

Cardiovascular Device – FDA Guidance

Dental Device – FDA Guidance

IVD and ASR – FDA Guidance

Medical Devices with Antimicrobial Agents – FDA Guidance

Software for Medical Devices – FDA Guidance

Medical Device Risk Management – FDA Guidance

Quality System – FDA Guidance

Additional FDA Medical Device Guidance


International Medical Device Regulatory Guidance

Canadian Medical Devices Regulations

Medical Device Directive Guidance