The benefits provided to date are as varied as:
-Setting up of quality systems ISO 9001/13485 /GMP
-regulatory affairs (EEC, US, Canada ...)
-EC technical files for CE marking
-sterilization process validation & follow-up (EtO, gamma, steam...)
-product & process risk management file
-sub contractor management
-OEM files
-clinical evaluation, PMS
- process validation (IQ, OQ, PQ)
- biocompatibility plan
-providing in-house training sessions adapted to your needs and covering themes such as : regulatory, CE marking, risk management, sterilization processes, ISO 13485 ....