Tuttlingen – Whether data protection, quality assurance, marketing or compliance: not every medical technology company has a legal department, but is regularly confronted with legal issues. From March 16, the newly designed certificate course will provide basic knowledge of the most important specialist areas, in which well-known law firms and manufacturers will contribute their knowledge. Lawyers from the law firm Baker McKenzie provide an insight in an interview.
In medical technology, there is a wealth of regulations and laws that must be observed. The jungle of paragraphs is getting denser. It is all the more worthwhile to gain an overview with the certificate course “Practical knowledge of law in medical technology”. The speakers will be lawyers from the law firm Baker McKenzie: Dr. Frank Pfluger (Seminar “The Quality Assurance Agreement in the Framework of the EU-MDR”, May 24th), Dr. Tobias Born and Dr. In an interview , Matthias Scheck (seminar “The General Data Protection Regulation in a Medical Technology Company”, March 30) explain what, from their point of view, characterizes the course and what the participants can expect.
- What will the certification course be about? Which topics will you specifically address?
dr Pfluger: The basics of quality assurance agreements (QSV) for manufacturers of medical devices and other economic actors are presented. I will explain essential regulations, among other things in relation to contract manufacturers/component suppliers but also to dealers. Liability clauses are also presented. The feasibility of OEM/private label models and own brand labeling will also be discussed.
dr Born/Dr. Scheck: First and foremost, we will convey the essential basics of data protection law. The focus is on sharpening the understanding of the most important data protection requirements. One of the topics that we will specifically address will be the topic of direct marketing. From our daily consulting practice we know that there is often a need for information.
- What can participants look forward to?
dr Pfluger: Practically implementable understanding of the contractual coverage of regulatory and QM-determined interfaces; Overview of the contractual implementation of the EU-MDR using QAA.
dr Born/Dr. Scheck: A comprehensible overview, reduced to the essentials, of the main features of data protection requirements. The opportunity to interact and ask questions.
- Why is it important to deal with the different legal and contractual aspects?
dr Pfluger: QAAs are audited by notified bodies and inspected by authorities. Well managed QAA helps to avoid legal disputes with other players and to mitigate liability risks.
dr Born/Dr. Scheck: Violations of data protection law can lead to high fines, but also to loss of reputation. The best way to increase awareness of data protection compliance and pave the way to it is to have a basic understanding of data protection requirements.
- Why should those interested register?
dr Pfluger: In order to better understand the contractual mapping of your company's QM processes, to assess any deficits and optimizations and to minimize risks.
dr Born/Dr. Scheck: To seize the opportunity to benefit from the knowledge and experience of practitioners who have been working in the field of data protection for many years.
Further information and the possibility to register for the certificate course “Practical knowledge of law in medical technology” can be found under this link .
