We have moved!
Please find our new offices here:
qcmed GmbH
Quality Consulting Medical
Oldenburgische Str. 16a
53859 Niederkassel
T +49 (2208) 921 9315
F +49 (2208) 921 9317
We reliably guide medical device manufacturers, operators and users through the necessary requirements for medical device regulation.
We quickly and safely bring medical devices to regulatory approval, allowing you to focus on your business.
OUR SERVICES ARE AS VERSATILE AS YOUR REQUIREMENTS.
We serve medical device manufacturers, operators and users.
As a qualified and competent partner, we advise companies in Germany and throughout the world.
> Founders and developers
> Established companies
> Private institutions and health care organizations
We implement and improve quality management systems according to:
> ISO 9001 (2015)
> EN ISO 13485 (2016)
> ISO 15378 (GMP & ISO 9001)
> US-QSR (21CFR 820) cGMP
> MDSAP