We are accredited!

... according to DIN EN ISO/IEC 17025 for testing your medical device according to DIN EN 60601-1.

Our Service for Medical Products

We support manufacturers of medical devices throughout the product life cycle. We can assist you during each phase with our compliance engineering, technical documentation and testing laboratory.

Regulatory Jungle

Many paths easily used in recent years have become a dead end. We at Qualitätsplan know the usable paths and help you master them and finally reach compliance and CE marking for your product.

 

Our daily business

Whether regulatory affairs knowledge, the compilation of e.g. risk management or complete IEC 60601-1 testing, Qualitätsplan provides individual support wherever it‘s needed!

Testing Laboratory

Technical Documentation

Compliance Engineering

… and one common goal: Supporting our customers on their path towards a safe product!

Latest News

Qualitätsplan is present at the Medica 2017 in Duesseldorf. Take this opportunity and make a note of the dates 13th - 16th of November 2017!

It's published! On 05.05. in 2017, the MDR was adopted in Brussels, which enters into force on 25.05.2017. So at the end of the month, the three-year transitional period will run.

The international edition of the requirements for the QMS of a medical device manufacturer was published at the end of February this year. The German edition as DIN EN ISO will follow in the next few weeks – for now - there is no information. We at Qualitätsplan are also looking forward to the new issue...