MedTech as business is changing and getting more complex. For example, the technical complexity and regulatory requirements are something that are increasing as we speak. In addition, the user...
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Due to the changes in the medical device legislation in the EU, there’s a lot of things you need to know as a medical device manufacturer. That’s why we decided to start a blog post series in the...
We’re living in an amazing world where the new technologies and the science itself enable new kinds of miracles happen in saving peoples’ lives and in improving their well-being. In recent years,...
MedTech as a business is changing and getting more diverse. For example, the technical complexity, forms of digitization and regulatory requirements are something that are increasing as we speak....
MedTech as business is changing and getting more complex. For example, the technical complexity and regulatory requirements are something that are increasing as we speak. At the same time there is...
MedTech business is changing and getting more diverse. The technical complexity, caused mainly by digitization, is increasing. New technologies are being introduced at faster pace, the impact of...
In short, Design Controls (or the practices of design and development, as in ISO 13485) refers to the application of a set of formal quality practices and procedures to the conduct of product...
MedTech business is changing and getting more diverse. The technical complexity, different forms of digitalization and related regulatory requirements are increasing as we speak. And there is the...
The new Medical Device Regulations (2017/745/EU) (MDR), published in May 2017, will replace the existing Medical Devices Directive (93/42/EEC) (MDD) and the Active Implantable Medical Devices...
