Who is QME

Lydia Kluver

Quality Made Easy was founded by Lydia Kluver in 2010.
After more than 30 years of experience, working for several employers, she decided to set up a company of her own.

Quality Made Easy

Do you struggle with the piles of paperwork that are inevitable when launching your (IVD) Medical Devices onto the market? QME can make these processes a lot easier for you!

Our approach:

We show you the way through the labyrinth of regulations and standards that are applicable for design, development, production, and sales of (IVD) Medical Devices. Subsequently the implementation and maintenance of your EN ISO 13485 quality management system and compiling the documentation for your (IVD) medical devices will be much less effort.

Once you have discovered that a well-documented quality management system is not a burden but a source of valuable information and a way of finance management, we have reached our goal and work will consequently be more satisfying for you and your staff members.


QME has a broad expertise, we are not only experienced in EN ISO 13485 quality management systems, but we can also support your company in the CE marking process, and with training and education. By cooperating with a team of experts , a broad range of expertise can be offered to our ustomers.

EN ISO Quality Management

QME can assist you, as a subcontractor or manufacturer of (IVD) Medical Devices, with the planning, implementation and maintenance of you EN ISO 13485 Quality Management System.
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CE Marking

An (IVD) medical device can only be sold in Europe with a CE mark. By placing the CE mark on a product, the manufacturer declares that the product complies with the applicable European regulation ...
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The performance and reporting of audits, internally, or at the subcontractors, are annually returned assignments that are usually carried out by your QA manager or an auditor.

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Quality Made Easy
Lijsterbesstraat 8
7101 MA Winterswijk
The Netherlands
Tel: +31 6-27055455