- QMA transition to the new EU MDR and/or MDSAP
- Implementation of ISO 13485:2016
- Implementation of ISO 14971:2019 or ISO 14971:2012 or ISO 14971:2007
- Gap Analysis
- Design and Development of products from idea to market
- Risk Management
- Quality Management System Procedure(s) Generation
- Pre-market Submissions and Licensing (PMA, 510k, Registration, etc.)
- Technical File Generation and Maintenance
- Design and Development of products from idea to market
- Clinical Evaluations
- Post Market Surveillance
- Vigilance
- Remediation Projects or Initiatives
- 483 Response
