From infusion bags, insulin pumps and hypodermic syringes through to prosthetic knees, contact lenses and pacemakers: the term medical devices covers a wide range of applications. Each product has its own risk class. Whatever medical device you manufacture, Kuijpers can ensure that you comply with the EU Medical Device Regulation (MDR).
We have been building controlled environments to the highest quality standards for years. These are essential as your product is affected both by the upgraded MDR requirements and your stakeholders’ requirements. For that reason Kuijpers carefully considers how the manufacturing equipment is fitted into your cleanroom. Everything is tailored to the relevant risk class of your process.
We analyse your questions and needs and develop a suitable design, and are your committed partner for construction, maintenance and operations. This means we work together on long-term cooperation in your full facility lifecycle. Does your organisation need to expand or create rooms for medical device manufacturing? Or better integration of the existing equipment? We are keen to tell you more about our expertise.