The establishment of the company mdc medical device certification GmbH was commercially registered 25 years ago on December 10, 1996.

Already since 1994 “mdc medical device certification” was the name of a division of Dr. Müller-Lierheim GmbH and became legally independent when the company was founded in 1996.

Since the merger with the certification body for medical devices of ZDH-ZERT e.V. in 2000, mdc is based in Stuttgart. Further office locations are in Berlin, Tuttlingen and Vienna. In addition, the first non-European branch will be opened in Haifa (Israel) in a few weeks. In the past 25 years the number of employees has increased from three to over 100. In addition, there are around 70 freelance auditors, technical experts and inspectors. The daughter company of ZDH-ZERT e.V. is in the meantime not only one of the leading notified bodies and prequalification bodies, but is also the market leader in Germany regarding certification of QM systems in the area of medical aids .

mdc has always focused its activities on the field of medical devices and related areas. The range currently covers the activity as a notified body under Regulation (EU) 2017/745 for medical devices (MDR) and under Directive 98/79/ EC for in-vitro diagnostic devices (IVDD), as an accredited certification body for QM systems according to ISO 13485 and ISO 9001, as well as an accredited prequalification body in the field of medical aids. Recognitions in Ukraine and Taiwan, audits under the Medical Device Single Audit Program (MDSAP) within the framework of a cooperation and the organization of public face-to-face and online seminars on topics related to quality management and regulatory affairs complete the offer. Under Regulation (EU) 2017/746 (IVDR) mdc is at an advanced stage of the designation process.

On the occasion of the 25th anniversary of the company, the managing director Harald Rentschler, who took up this position when the company was founded, was handed out a honorary certificate from the Chamber of Industry and Commerce in Stuttgart by its the managing director Dr. Susanne Herre. He thanks everyone who has accompanied the company on its successful path.