OUR PLUS FOR YOU

Our PLUS FOR YOU is our love of our work and the passion that goes into it.

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
> MDSAP

The international regulation of the medical devices market demands an international approval strategy. Qcmed supports you in creating a tailored concept.

CE Marking

MDR 2017/745 EU Medical Device Regulation
Active Implants (90/385/EEC)
Medical Devices (93/42/EEC)
In-vitro diagnostics (98/79/EC)

> Product classification
> Selection of the conformity assessment procedure
> Technical documentation
> Selection of notified body
> Implementation and coordination of regulatory approvals
> National registration

Risk Management

> Risk analysis and management
> EN ISO 14971, EN ISO 22442, IEC 80001-1
> Risk management file
> Post-marketing surveillance
> Monitoring and reporting system
> (MEDDEV, MPSV, MDR)

USA: Your way to FDA

> Classification
> Documentation (DMR)
> 510(k), IDE, PMA
> Establishment Registration
> International device listing
> Other countries upon request (e.g. Canada, Australia)

Technical Documentation

DMR, DHF

> Conforming to standards, ready for submission
> In accordance with your Notified Body
> Instructions for use, labelling
> International strategy

A QM System should not only meet regulatory requirements. A good QMS should be a valuable management tool, with which you can optimally exploit your company’s potential for improvement. This saves time and money.

Our Service

> Selection of Notified Body
> Setup, maintenance and review of your QM System
> QM Manual, SOPs and work instructions
> Process analysis, visualization and optimization
> Risk management and CAPA
> Audits and system analysis—internal and for suppliers

Production/Hygiene

> Hygiene requirements
> Production in cleanrooms
> Validation of sterilization processes
> Management of test equipment
> Process validation
> Refurbishing of medical devices
> Package validation

We implement and improve Quality Management Systems according to:

> ISO 9001
> EN ISO 13485
> ISO 15378 (GMP & ISO 9001)
> US-QSR (21CFR 820) cGMP
> MDSAP

Your product is in good hands.

One stop shopping. Together with our trusted partners, we organize and offer comprehensive testing.

Software validation

Planning of valid test programs

Consulting and testing strategy for …

> Biocompatibility (ISO 10993, USP)
> Electrical safety, EMC
> Usability
> Test for implants ISO 5840, ISO 7198
> Extractables

Improve your competency with our tailored training. Broaden your knowledge via individual seminars and workshops.

Our service

> Up-to-date information about medical devices and quality management
> By far the best: seminars at qcmed
> Practical: seminars in your office
> Learn in small groups
> Hotel reservation service

We are looking forward to your inquiry.
info@qcmed.de

DIN EN ISO 9001 certified