USA
- 510k Preparation & Submission
- Predicate Device Identification
- Q Submissions/ Pre Submissions
- De Novo Applications
- 513g Classification Requests
- Breakthrough Designation
- PMA
- IDE & Pre IDE
- Manufacturing site registration & device listing
Quality & Management systems design, development, implementation and maintenance to:
- ISO 13485 Quality System
- MDSAP
- QSRs (Part 820)
- ISO 9001
Europe and the UK
- MDR (EU) 2017/745
- IVDR (EU) 2017/74
- EU Authorised Representative
- UK Responsible Person
Preparation of CE Marking Technical File / Design Dossier:
- Technical and Design File Reviews
- Risk Management Files
- Medical Device/IVD classification
- EU Authorised Representative
- Product Risk Assessment
- Post Market Surveillance and Reporting
