Regulatory Training
Regulatory training
Valpas Certifications offers regulatory training related to Regulation (EU) 2017/745.
The new regulation concerning medical devices, the Medical Device Regulation 2017/745, referred to as MDR, has been set into force. MDR has an impact on all medical device manufacturers and must be understood by the manufacturers in order to keep the products on the European Market.
With our training you are able to get an overview on how MDR addresses product classification, basic requirements, technical documentation, clinical aspects, post-market surveillance and quality management systems. After the training you are able to understand how the changed legislation is affecting the organizations within the field and what responsibilities and obligations the manufacturers have.
Our experts with more than 20 years of experience from the field will give you easy-to-understand examples on how the legislation has affected the field and provide you the core understanding of the legislation main principles.
Regulation 2017/45 (Medical Device Regulation) Training
Our training related to MDR is structured to cover the following:
- The needs of the manufacturer
- Ensuring the safety of the device
- Traceability and manufacturing
- How to place the device on the market and the subsequent activities