DHF, DMR, DHR, and 21 CFR 820.30 / ISO 13485.7.3 Documentation

This comprehensive training dives into the Design History File (DHF), Device Master Record (DMR), Device History Record (DHR), and discusses the regulatory requirements that impose these requirements.

Areas Covered in the Session:-

• The U.S. FDA's DHF
• The EU's MDR and the Technical Documentation File
• Design Control vs. a Product 'Snapshot in Time'
• DHF /D&DF Required Contents
• The DMR and DHR
• Future Directions.

Background:-

What are the FDA and ISO requirements for Design History Files, Device Master Records, and Device History Records?

This webinar will discuss the existing requirements, how to meet and document them, and their inter-relationships.

Why Should You Attend?

Medical device manufacturers must meet different product documentation for the U.S. and the European Union. The Quality System Regulation mandates Design Control and the Design History File (DHF). ISO 13485:2016 has identical requirements under Design and Development. The Quality System Regulation mandates Device Master Record and Device History Record; similar requirements required in ISO 13485 are stated differently.

Who Will Benefit? 

This 60-minute online course is intended for professionals in the Medical Device Industry. 

• Regulatory Affairs
• Quality Assurance
• Production
• R&D and Engineering.