The Blueprint Blog

Challenges for small and medium size enterprises brought by the new EU Medical Device Regulation (MDR)

Have you heard? The EU Medical Device Regulation (MDR) has now been in effect for almost a year. The impact for Medical device and diagnostics manufacturers are likely to bring huge challenges to implement the new requirements. Whether you are a start-up in the early phase, further advanced development enterprise, or even an established medical device company, do you understand the current realities of EU MDR compliance?The fact is, there are challenges that will impact just about every medical device company operating or planning to operate in the EU. However, small and medium sized enterprises with limited resources may find it difficult to adapt to changes and implement these requirements in a timely manner.

Are you aware of the impact for your company?

In our white paper, Blueprint together with our advisor board member Prof. Dr. Hanns-Peter Knaebel, express our concern over the burden of the certification process. We review the aspects the new legislative framework has on medical device development, particularly for smaller businesses, and offer some insight on how further technological innovation in the manufacturing sector can help in the wake of stricter regulations.

📢A little insight into our daily business.

🔁 Rapid product development, as well as individual and serial production, is necessary to react agile and fast to internal and external events.
Often, classical production processes can no longer cope with the increasing complexity, speed or batch size. This is becoming a greater challenge. Flexible and innovative manufacturing technologies are the key to the best solution of quality and efficiency.

By lowering fixed costs and reducing procurement complexity, product development and time-to-market can be achieved faster and more cost-efficient. Feel free to visit our website and read the article for more information. https://lnkd.in/eJpMMt-w

‍💥 Product Manufacturing, Simplified.

We are serious about our committment to high quality offerings for our customers and place implementing such internal systems to guarantee this service at the highest priority.

Less than 3 months after founding Blueprint, we are proud to have already successfully achieved certification according to DIN EN ISO 9001 standards.

We will continue to improve and grow our business and strive to offer only the best in service and quality.

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