Medical Device Certification
2M has extensive expertise and knowhow in medical device certification.
We can support the whole process from defining and checking the intended use, doing the risk analysis, selecting the applicable standards, executing the required verification and validation tests that comply with the standards and creating the required technical product documentation.
We have done this for the following device classes: CE-IVD, CE1m, 2a and 2b products.
For certain products 2M and sister organizations have ISO13485 certified production facilities.
2M can assist or take the complete responsibility in quality management systems, product certification and regulatory from early stage up to commercial product.
Medical device certification is not offered as a separate service but is offered for client specific OEM product developments or research projects.
Industrial ATEX device certification
Besides medical devices 2M Engineering also develops and produces industrial and environmental sensor solutions. Over the years we have ATEX certified a number of products and solutions. This experience we now apply to new industrial sensor developments.
Industrial ATEX device certification is not offered as a separate service but is offered for client specific OEM product developments.
Standard CE Certification
Depending on the application and intended use we also do more straightforward standard CE certification. This is for example used for various sports trackers. We execute the complete CE certification process in many of those cases for our clients.