Do you need to establish a Technical Documentation (TD) according to Annex II+III, MDR 2017/745 or transfer an existing documentation according to MDD into MDR? We are familiar with both and can help you on different levels:
- Review of the current situation with a gap analysis regarding MDR
- Consulting in the structuring of the various technical documentations
- Support in the many subtopics such as UDI, Basic UDI-DI, Risk Management, Labeling, Packaging, PMS, PMCF, PSUR, SSCP, CER, Essential Safety and Performance Requirements (GSPR), Classification, Standards Update, Declaration of Conformity, Swissmedic Notification and many more
Do not hesitate to contact us - we will help in an uncomplicated way and exactly where you need it.