Medical device training courses
CE marking training courses
- Awareness on requirements of EU MDR (Medical Device Regulation) (EU) 2017/745
- Training on Implementation of Medical Device Regulation for CE Marking.
- MDD to MDR Transition Training.
ISO 13485 training courses
- Internal Auditor training on EN ISO 13485:2016 / ISO 13485:2016
- Awareness training on the requirement of EN ISO 13485:2016 / ISO 13485:2016” Course.
Compliance training courses
- Awareness on requirements of Risk Analysis as per EN ISO 14971:2012.
- Awareness on requirements of Clinical Evaluation (MEDDEV 2.7.1 Rev. 4) and PMCF (MEDDEV 2.12/2 Rev. 2)
- Awareness of Unique Device Identification (UDI) requirements.