Description
1. Provide all technical consultation services for CE MDD and MDR technical file preparation.
2. Preparation of the quality management system according to ISO 13485:2016.
3. Preparation of the quality management system according to ISO 9001:2015.
4. Clinical Evaluation strategies, plans, and reports.
5. Risk Management Files
6. MDR PMS (PMS plan, PSUR) / PMCF(plan, evaluation report) consulting and compilation; Canadian Summary Reports.
7. Trainer on:
o ISO 13485:2016
o EN ISO 14971: 2019
o EU MDD / EU MDR
o Internal audit (ISO 19011)
o CEP/CER
