Your partner for all medical device related questions
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 demand or on an ongoing basis
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.
Focused on the goal
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.
Clinical data through clinical studies
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.
Quality management for medical devices
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.
