ISO toolkit

MDR Toolkit

EU Medical Device Regulation 2017/745 compliance

A complete documentation set for EU Medical Device Regulation (MDR) 2017/745 compliance, covering technical documentation, clinical evaluation, post-market surveillance and risk management.

What's inside

• MDR technical documentation structure
• Clinical evaluation and post-market clinical follow-up templates
• Post-market surveillance system and vigilance records
• Risk management file aligned to ISO 14971
• UDI, labeling and economic operator documentation