Regulatory Lab: MDR-Workshops
Service Description
Our company-specific modular MDR-workshops offer hands-on training on various relevant topics of the Medical Device Regulation (MDR) and the general medical device field. These intensive workshops are divided into compact and practice-oriented modules that cover the key requirements of each respective topic. An example is the Module 1 workshop “Regulatory Requirements for Your Medical Device,” which provides a compact and practice-oriented overview of the key regulatory requirements in the medical device field. The workshop content is tailored to the company’s specific needs beforehand, and additional topics can be booked in modular fashion. Thus, specific topics such as Clinical Evaluations, Technical Documentation, and Quality Management can be booked individually and customized to the company's needs. The content is structured in such a way that participants are optimally prepared for the MDR requirements and can directly apply their knowledge. A regular workshop usually lasts two days and includes gap analyses in the form of checklists as well as the creation of an action plan. Practical exercises additionally introduce the creation of documentation and processes tailored to the individual company. Participants also receive current informational materials and clinical insights from practice.
Our workshops provide companies with the opportunity to not only further educate individual employees but also empower their team to implement the MDR and other regulations within the company. Our goal is to strengthen and support the team in jointly managing the various regulatory requirements and to guide the transition from overview and understanding to practical implementation. Keywords: MDR Workshop, MDR, Medical Device Regulation, Modular Workshops, Hands-On Training, Medical Devices, Regulatory Requirements, Practical, Gap Analyses, Action Plan, Clinical Evaluation, Quality Management, Usability, Post-Market Surveillance (PMS), Post-Market Clinical Follow-Up (PMCF), Charité - Universitätsmedizin Berlin
Provider & Contact
Pricing is available to registered users. SMEs receive significant state-aid reductions (GBER) — or, depending on the call, free services during the funded project. Sign in or register to see the price for your organisation.
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