If GDPR applies to your business, it’s worth working to make your systems GDPR compliant. You should consult with your business’s legal team on what exactly compliance means to them, but here are some key considerations: Establish the legal basis for collecting personal data. In most cases, it will be that you have obtained that […]
If GDPR applies to your business, it’s worthwhile to know a few of the key objectives of the regulation. First, providing individuals with greater control over how their personal data is used is the heart of the GDPR. A major part of compliance is shifting from operating on the assumption that you can use customers’ […]
GDPR is fairly broad in terms of the businesses that it regulates. It applies to two broad strata of companies: (a) those that are “established” in the European Union and (b) those that process data of European Union residents. If your business has a branch in the European Union, seeks to do business with any […]
European Union’s General Data Protection Regulation (GDPR) In the 18 months since the European Union’s General Data Protection Regulation (GDPR) has gone into effect, more than $126M in fines have been levied against companies who haven’t complied with the law, including significant fines for Google, British Airways, and Marriott, and all signs point to continued, and possibly even […]
Documentation of QMS processes, quality events, and workflows is critically important. Sometimes the notion of documentation can create angst within a company. Sometimes the idea of documentation is viewed as overly burdensome and often times unnecessary with little value added. In my experience, most companies do create quite a few burdens and obstacles regarding documentation. […]
EU regulations require manufacturers to produce a PMS plan as part of their technical documentation. The plan must be implemented to produce PMS reports (PMSRs) or Periodic Safety Update Report (PSURs) depending on the class of the device. PMSRs apply to class I medical devices under the MDR, and to class A and B devices […]
The Medical Device Regulation 2017/746 (MDR) defines PMS as: All activities carried out by manufacturers in cooperation with other economic operators to institute and maintain a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market, or put into service for the purpose of […]