Paper-based Quality Management Systems are now (almost) a thing of the past (it’s sooo 20th century…). But in some cases, printing records and documents from the eDMS is necessary, or at least exporting them to PDF. The requirements for paper documents are the same as digital documents. But, unlike electronic formats, physical misplacement or loss […]
What is Document Control? Automated vs Paper-Based?
Although this process can be extremely complicated and interlaced in large corporations, the requirements for Document Control are actually quite simple. Let’s give a look at them: ISO 13485:2016 – it’s all in two paragraphs, §4.2.4 and §4.2.5: (a) Documents must be approved, i.e. have signatures (electronic or handwritten); (b) If reviewed or modified, they […]
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 […]