Möller Medical was the first customer to receive the MDSAP certificate from MedCert on March 22, 2018.
“We have thus succeeded in passing this new and very demanding audit procedure as one of the first medical technology manufacturers in Germany. In this issue we have covered ISO 9001:2015, ISO 13485:2016 and Directive 93/42/EEC. We also met country-specific requirements for the USA, Canada, Australia and Brazil.” Fabian Flügel from Quality Management explains.
Behind the scenes, preparations for the next major regulatory challenge, MDR, have already begun.
Contact: Fabian Flügel (QM)