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...
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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...
New year and new beginnings – but first it’s time for 2018 year-end list! We took a look at which blog posts on Innokas Medical’s Business Blog were the most popular ones; so here are our top 10...
Finding answers? Welcome! - This is an unofficial guidance which is intended to assist medical device OEMs by sharing some tips on how to prepare to the new European Medical Device Regulations,...
MedTech as a business is changing and getting more diverse. For example, the technical complexity, forms of digitalization and regulatory requirements are something that are increasing as we...
In our previous MDR related blog post we discussed on how to ensure that your existing products are compliant with the new medical device regulation. Now we’re sharing some tips on how to get...
Medical device industry is commonly characterized as regulated domain. Before introducing new medical devices to the market, there’s much more than simply coming up with an innovative idea,...
