The relationship between the FDA and ISO 13485 goes back a long time. The ISO standard has been in the list of General Consensus Standards since the dawn of times, but there has never been a full alignment between 21 CFR 820 (QSR) and ISO 13485. It’s like these couples that have been together forever, […]
New Medical Devices Regulation & Risk Management
The revised Medical Devices Regulation (MDR) will change the regulatory environment of medical devices in Europe to a more stringent one. Compared to the MDD, the MDR promotes a life-cycle approach similar to what the US FDA and many international standards advocate. MDR highlights the importance of medical device risk management. Although risk management has […]
SoftComply eQMS for Medical Device Companies has arrived!
SoftComply is pleased to announce SoftComply eQMS, the first Atlassian add-on addressing the needs of life-science, medtech and pharma companies has arrived. SoftComply eQMS: • fast-tracks the implementation of a compliant Quality Management System for medical device companies; • is comprehensively focussed on the EU and US based markets, and helps users fulfil their requirements […]
A Fully Customizable Quality Management System for Your Medical Device Company!
Numerous companies struggle to enter medical device domain due to strict regulatory requirements for medical device products. Similarly, large medical device manufacturers have a difficult time finding suppliers that are not only innovative but also compliant with the regulatory requirements of medical device domain at the same time. A Quality Management System (QMS) is a […]