Regulatory
- From MDD to MDR compliance
- From IVD to IVDR compliance
- MDSAP compliance
- Is the product defined as a medical device?
- Medical device / IVD classification
- Regulatory strategy including claims
- Communication with Notified Body and authorities
- Product labeling
- CE marking
- Regulatory support to design control
- Regulatory support to clinical evaluation and investigation
- UDI
- Product registration - US - EU - Canada - Kina - APAC Latin - America, etc.
- Vigilance and vigilance reporting
- Post Market Surveillance and PMS report
Legislation
- MDR - Regulation EU 2017/745
- IVDR - Regulation EU 2017/746
- FDA 21 CFR part 820
- SOR / 98-282
Quality Assurance
- ISO 13485
- MDR / IVDR
- MDSAP compliance
- Quality Systems structure and coherence
- SOP creation / update
- Training systems and training compliance
- Design history file
Design Control
- Project governance and project approach
- Device development planning
- Design development process
- Project feasibility
- Development candidate
- Design input
- Risk analysis ISO 14971
- Design output
- Design review
- Design verification
- Design validation
- Technical file
Audit
- Internal audit
- External audit
- Inspection from Notified Body or authorities
- Project Management
- Deviations and CAPAs
- Complaint handling
- GAP analysis
- Supplier approval and supplier metrics
