Technical Documentation
| Page | Covers |
|---|---|
| Overview | Annex II/III content, retention obligations, common NB findings |
| SSCP | When required (Class III, implantable), content, NB validation |
| Risk Management (ISO 14971) | RMF structure, ISO 14971 process, integration with PMS and clinical evaluation |
| QMS Requirements | ISO 13485 scope, NB QMS audit, Swissmedic and QMS |
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