Our PLUS FOR YOU is also your satisfaction–
during the planning, implementation and training with you and your team.
The unique integrated approach of qcmed combines the goal of product approval with the successful development of your quality management system.
Strategic planning and practical implementation are combined in a consistent concept from which both employees and management will benefit.
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