When correctly applied, regulatory affairs and compliance doesn’t impose any costs on industry and, it certainly ensures the highest level of safety and quality for patients, users, third parties and the environment.
When regulations are incorrectly applied, the costs can quickly spiral out of control resulting in astronomical overheads for the business. But more importantly, there can be serious risks to human health which are immeasurable.
Many notified bodies (NBs (certifying bodies designated by departments of health)) throughout Europe have been and still are still under-performing since the publication of the MDD (Medical Devices Directive) in 1993. Effects of this began to publicly emerge due to media coverage of the French PIP scandal, where a manufacturer used non bio-compatible materials for breast implants
Today we are seeing more and more consequences with Boston Scientific accused of using counterfeit materials that harm tens of thousands of women and patients are being fitted with incorrectly sized hip implants
Read more
