EXPLORING THE FUTURE OF
YOUR MEDICAL DEVICES Research & Development Consulting & Implementation QM-System-Integration & Documentation Certification & Post-Marketing Development

Medicoforum develops your MDR-conform Medical Devices to market.

Medicoforum is a successful provider of services for the implementation of Medical Devices in Quality Management Systems and the preparation of the entry to the market place.

Extensive completed projects have demonstrated that Medicoforum is a reliable partner serving pharmaceutical and biotechnology companies.

Medicoforum is based in Hannover, Germany and is linked to a network of international organisations.

The service organisation is well aware that trust in people is the basis for building strong customer relationships. We offer a consummate balance of science and business, which allows us to achieve clinical excellence and technological innovation whilst maintaining the highest quality standards.

Medicoforum has earned an excellent reputation for quality work with our services in Europe and the US.

Since 2003, we have managed to constantly adapt to the changing requirements and would be proud to assist you in your current or upcoming projects.

Medicoforum brings
your ideas to market.

With expert knowledge, long term experience and creative ideas, Medicoforum is your partner to realise your product ideas. We involve our network of international co-operations and the specialised expertise of associated colleagues.

We compile the Medical Device Dossiers, complete data as required and implement appropriate changes in the life cycle management. With tailor-made solutions, we establish Quality-Management-Systems according to the product or the portfolio of products. By utilisation of synergy effects, we shorten the time to market through optimisation of processes.

In order to comply with the legal requirements, we co-operate closely with specialised attorneys. To protect your Intellectual Property, we guide you together with experienced patent attorneys.

Medicoforum is your partner and guides you through the complex regulatory framework for Medical Devices.

Medicoforum guides smart ways to the point of sale.

Medicoforum continually supports new certifications according to national and international guidelines.

Furthermore, our focus is to compile all required regulatory documents and Medical Device dossiers and to conduct clinical trials according to ICH-GCP (Auditing and Monitoring are available).

Main activities at present comprise:

Worldwide certifications

Certification of Medical Devices on an international basis (for instance EU, Non-EU-countries, USA and Canada)

High-quality dossiers

Production of high-level quality Medical Device dossiers which ensure certification today and allow further development tomorrow.

Clinical studies

Generation and compilation of clinical data through Clinical Trials according to the Medical Device Law and GCP-standards.

Quality Management Systems

Establishment, maintenance and update of Quality Management Systems on a high level of experience.

Familiar with authorities worldwide

Conduct of CE certification in close co-operation with Notified Bodies and responsible governmental institutions.

Medical Devices by Medicoforum

Development of Medical Devices within Medicoforum’s QMS for immediate availability to our clients.

Quality management – our system to success

Quality Management Systems (QMS) play an essential role in the framework of legal requirements to place a Medical Device on the market.

There are different normative and legal requirements, such as the MDR (Regulation EU 2017/745), DIN EN ISO 13485 or FDA 21 CFR part 820, which are continuously developed forward.

As we have our own QMS in place, clients may implement their product into our system, which allows them to delegate their obligation as a legal manufacturer.

Medicoforum gives advice, constructs and implements Quality Management Systems according to the individual requirements of the particular product and associated processes.

Visit Medicoforum

Our focus:
Contract services for Medical Devices including both single- and full-service.

Projects overall:
45+ Medical Device development projects (from idea to market)
120+ Dossiers
20+ Patents

Competence status:
Certified acc. to DIN EN ISO 13485:2016, Medical Device Regulation (EU), Medical Device Act (Germany), in-depth knowledge of GCP and GMP, patent law and up-to-date expertise.

You’re welcome.

Managing Director:

Dr. (MD) Uwe Albrecht,
FIBMS, MFPM (Dis.), MICR, CSci

Tel.: +49 (0) 511 806 859-6

contact@medicoforum.com

Medicoforum GmbH
Misburger Straße 81 b
D-30625 Hannover
Germany

Economic data:
founded in 2003
10+ in-house specialists organised in a flat hierarchy
20+ satisfied clients

Project partners:
Mediconomics GmbH (Europe/USA/Canada)
Mermedic GmbH (Switzerland)
MedCert GmbH (Germany)

EXPLORING THE FUTURE OF
YOUR MEDICAL DEVICES Research & Development Consulting & Implementation QM-System-Integration & Documentation Certification & Post-Marketing Development

Medicoforum develops your MDR-conform Medical Devices to market.

Medicoforum brings
your ideas to market.

Medicoforum guides smart ways to the point of sale.

Worldwide certifications

High-quality dossiers

Clinical studies

Quality Management Systems

Familiar with authorities worldwide

Medical Devices by Medicoforum

Quality management – our system to success

Visit Medicoforum

You’re welcome.

Contact

Menu

Legal information

EXPLORING THE FUTURE OFYOUR MEDICAL DEVICES Research & Development Consulting & Implementation QM-System-Integration & Documentation Certification & Post-Marketing Development

Medicoforum develops your MDR-conform Medical Devices to market.

Medicoforum brings your ideas to market.

Medicoforum guides smart ways to the point of sale.

Quality management – our system to success

Visit Medicoforum

You’re welcome.

Contact

Menu

Legal information

EXPLORING THE FUTURE OF
YOUR MEDICAL DEVICES Research & Development Consulting & Implementation QM-System-Integration & Documentation Certification & Post-Marketing Development

Medicoforum brings
your ideas to market.