The new Medical Device Regulations (2017/745/EU) (MDR) will replace the existing Medical Devices Directive (93/42/EEC) (MDD) and the Active Implantable Medical Devices Directive (90/385/EEC) (AIMDD)....
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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...
MedTech as a 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...
Across industries, the pace to introduce new products is increasing. This puts pressure to shorten the design and development cycles. Medical devices are no exception in this respect.
Do you have an idea of a medical device? Or have you already started to develop your medical device? Do you want to enter, e.g., EU or US markets?
Finding answers? Welcome! - This is an unofficial guidance which is intended to assist medical device OEMs by answering to some common and basic questions concerning quality compliance and regulatory...
There’s few common trends in the medical field, which have a clear effect to the development of new medical products. The first one is the constantly changing jungle of rules and regulations, which...
Across industries, the pace to introduce new products is increasing. This puts pressure to shortening the design and development cycles. Medical devices are no exception in this respect.
When you’re working in medical industry, it’s a fact that regulations and standards are something that companies need to follow and they’re coming stricter for everyone continuously. This is...
