Revised March 2019 to include EU MDR regulations, second edition.
For the Engineer or scientist starting out in Medical devices, the array of regulation across the globe can be daunting.
While the online world provides a detailed and perrinial source of current inf.
Many companies need to fulfil regulation from multiple jurisdictions along with Design, GMP and manufacturing requirements.
This short book introduces the key themes associated with Medical Device Regulation within the EU and Europe.
Revised March 2019 to include EU MDR regulations, second edition.
For the Engineer or scientist starting out in Medical devices, the array of regulation across the globe can be daunting