Medicoforum is an experienced consultant and service provider for the certification of medical devices under MDR as well as for the establishment or maintenance of your quality management system.
External advice is often required for Clinical Evaluation Reports (CERs) and Biological Evaluation Reports (BERs) as well as in the areas of Post-Market Clinical Follow-Up (PMCF) and risk management. This extra support can be especially useful in times of transition.
Medicoforum is based in Germany (Hanover) and is part of a network of international organisations.
Extensive successfully completed projects prove that Medicoforum is a reliable partner for pharmaceutical and biotechnology companies. We believe that trust is an essential basis for building strong client relationships.
We ensure a perfect balance between science and business, both analogue and digital, which enables us to achieve clinical excellence and technological innovation while maintaining the highest quality standards. Our interdisciplinary approach will streamline your products route to market.
Since 2003 we have been successfully adapting our strategies to meet the continuously changing requirements and would be pleased to support you in your projects.
What is Medicoforum's core competency?
Medicoforum is an experienced consultancy specialising in regulatory services and the certification of medical devices in accordance with the Medical Device Regulation (MDR). We support manufacturers in the preparation of all necessary documents such as clinical evaluation, PMCF or risk management.
For which risk classes can Medicoforum provide support?
Medicoforum is experienced with medical devices of all risk classes according to the MDR – from the lowest class I to the higher classes IIa, IIb and III, where a notified body must be involved.
How does Medicoforum support the MDR certification of medical devices?
Medicoforum accompanies manufacturers through the entire MDR certification process. We prepare the necessary documents such as the clinical evaluation, risk management and quality management system. If necessary, we also coordinate the cooperation with your notified body for the conformity assessment.
What support does Medicoforum offer for clinical data and studies?
Medicoforum advises you on questions of clinical evaluation and post-marketing surveillance (PMCF). If required, we plan and conduct clinical studies in cooperation with our sister company and full-service CRO Mediconomics to collect the necessary clinical data for the certification of your medical device.
Does Medicoforum offer quality management services?
Yes, we advise, design and implement quality management systems (QMS) according to the individual requirements of your product and the associated processes. As we have our own QMS, clients may integrate their products into our system and delegate the manufacturer obligations to us.
Can Medicoforum act as the legal manufacturer?
Yes, Medicoforum can assume full manufacturer responsibility in terms of medical device law and coordinate the entire supply chain and production for you. We ensure the MDR-compliant certification of your product and relieve you of regulatory obligations.
Does Medicoforum support the reimbursement of medical devices?
Yes, we can prepare the application for classification as a prescribable medical device for you and apply for inclusion in Annex V of the German Drug Prescription Ordinance.
Medicoforum is your partner when it comes to establishing or maintaining the marketability of your medical device or securing it for the future. With our consulting services we support you and your company in all matters concerning medical devices.
We provide support on an ongoing or as-needed basis in compliance with national (e.g. MPDG) and international requirements (e.g. MDR).
Our focus is on supporting you with targeted services in such a way that you can efficiently meet the regulatory necessities as well as the requirements of your Notified Body.
We keep a clear view when it comes to not losing sight of the goal in the thicket of innovations.
Regulatory requirements can be complex, and frequent innovations can make navigating the guidelines difficult. Throughout the process, the experienced team at Medicoforum never lose sight of our objectives. We focus the preparation or revision of your documentation or its components such as Clinical Evaluation Report (CER) or Biological Evaluation Report (BER), Post-Market Clinical Follow-Up (PMCF) or risk management.
When clinical data for medical devices are required, our sister company Mediconomics GmbH provides support as a competent partner and service provider for clinical studies.
For us, it is important not only to describe theoretical quality management, but to generate feasible and actionable QM systems. Medicoforum is not only certified as a medical device manufacturer by a Notified Body itself, but also offers consulting services for the creation and implementation of your quality management system.
MDR-compliant certification of medical devices in all classes. MDR-compliant certification of medical devices in all categories. Preparation of all necessary documents for the technical documentation clinical evaluation, PMCF or risk management.
Creation of up-to-date and professional medical device dossiers and technical documentation that ensure certification today and enable further development tomorrow.
Generation and compilation of clinical data from studies compliant with MDR, ISO 14155 and Good Clinical Practice (GCP) requirements. For your clinical evaluation.
Establishing, maintaining and updating quality management systems with experience and passion for efficient solutions.
Implementation of CE certification acc. to the MDR in close cooperation with Notified Bodies and your other project partners.
Development of medical devices within our QMS for immediate availability and benefit of our customers.
Medicoforum Factsheet
Our focus: MDR consulting and services for medical devices such as quality management, risk management, clinical data and studies or clinical evaluation. Project overview: 45+ medical device projects (from idea to product) 120+ dossiers 20+ patents Competence status Certified according to DIN EN ISO 13485:2016, Medical Device Regulation (MDR), Medical Device Law Implementation Act (MPDG), expert knowledge in GCP and GMP as well as ISO 14155 and always up-to-date specialist knowledge. About the company: Founded in 2003 10+ in-house specialists a large number of satisfied customers Project partners: Mediconomics GmbH (Europe/USA/Canada) DNV MedCert GmbH (Germany)
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Managing Director:Dr. (MD) Uwe Albrecht, FIBMS, FFPM (Dis.), FICR, CSci Phone: +49 (0) 511 5151 18 90 contact@medicoforum.com
How may we help you?
Medicoforum GmbH
Misburger Straße 81 B
30625 Hannover
Germany
Tel.: +49 (0) 511 5151 18 90
