RAS627

Examine basic principles and challenges supporting regulatory systems in specified countries.

Identify and interpret the medical device regulations (EU MDR).

Create regulatory plan and expand into a global market introduction strategy.

Interpret risk-based classification regulations.

Describe clinical evaluation process, technical documentation, harmonized standards, and guidance documents that satisfy safety and performance, quality management system and labeling requirements.

Determine the conformity assessment pathway and post-market surveillance plan.

Manage medical device registration and licensing requirements.

Identify CE marking process and analyze global requirements involved in marketing regulated products.

Discuss Medical Device Single Audit Program (MDSAP) and personnel training requirements.