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Ensuring quality for the customer by complying with new laws and regulations

Martin Golverdingen is an experienced NPI- and Test Engineer and has been working at TMC since September. He has recently completed his first project via TMC. During this project, Martin and three other Employeneurs, helped a medical company to comply with the new Medical Device Regelation (MDR). Time to check in and ask about Martin’s experiences so far.

What did your first project at TMC look like?

I work at the business cell Manufacturing Support, and together with three colleagues from Field Service we worked on a project at one of our clients for eight months. It was nice to work on a project with colleagues from another expertise cell. You hereby get to know other colleagues, and for the client it is useful to get knowledge from several disciplines.

"It was nice to work on a project with colleagues from another expertise cell. You hereby get to know other colleagues, and for the client it is useful to get knowledge from several disciplines."

Companies have until 2021 to comply with a new EU regulation for medical devices. It takes a lot of time and effort to make sure all necessary documentation is available, because these documents need to be reviewed, justified and possibly modified. TMC has a lot of experience in Test & Integration and regularly assists customers with similar processes, such as obtaining ISO certifications. That is why TMC was asked to make sure the company was ready for the new regulation in time.

That sounds like an extensive project. How do you handle this?

It is a very broad project. To start, we had to look at what these new regulations mean and we needed to make clear what it meant for the company. Their compliance department is very involved in this as well. It was up to us to implement this plan step-by-step.

"I discovered that I really like to work for small companies or startups because they want to make progress and because I can show my added value as a consultant and help them move forward."

We started analyzing the product requirements. We then developed tests to prove that the product actually meets these requirements. After that, the company reviewed the tests that we had created and conducted. Another part of the project was to optimize the traceability of the documentation. We helped to ensure that the selected software for the documentation traceability was in line with the existing work processes.

How did you experience your first project at TMC?

I really enjoyed my first project. Especially the great culture at the client was very pleasant. I discovered that I really like to work for small companies or startups because they want to make progress and because I can show my added value as a consultant and help them move forward.

What I liked the most about the project was the research that had to be conducted and the new knowledge I have gained. It feels very satisfying that we were able to successfully finish the project, also thanks to the great colleagues at the client. I am curious to find out what else TMC has in store for me!

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