Process
- Reusable medical devices, reprocessing validation as per EU MDR 2017/745- Annex I (GSPR 10, 11 & 23), Annex II Technical Documentation
- FDA Guidance: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling US FDA (510K)- Premarket submission requirements (510(k), PMA, De Novo, HDE, IDE) March 2015, with Appendix E updated in June 2017
