Meet our expert Maggie Holland
When Margareta joined SDS she brought 20 years of extensive experience in hands-on quality assurance, development and production of risk class I – III medical devices, pharmaceuticals and biologics covering product design and change control, inspections, process improvements and product recalls. She spent significant time of her medical device career in the US where she worked with quality assurance during production of medical devices, companion diagnostics but also pharmaceuticals and biologics. At SDS, Margareta assist clients in establishing compliance with regulatory requirements towards EU and US market, CE mark certifications and overall QMS. She has full understanding of ISO 13485:2016, MDD/MDR and QSR/FDA 820.
“There are many requirements to the MDR, but the main reason the MDR was created was to improve safety and effectiveness of medical devices and a QMS is now required for all risk classes. It´s important that manufacturers remember that the new requirements are here to control and improve the safety of your medical devices, for the total life-cycle; which includes risk management and post market surveillance and a more detailed Technical File. Establish a strong QMS, it will make the company more efficient and reduce key quality challenges.”