We advise manufacturers and other businesses comprehensively on the implementation of the regulatory requirements of the new legal background. We regularly organise workshops in which we train – tailored to the requirements of our client in each case - staff on the new legal requirements. We are well aware of the challenges posed for businesses by the many unclear areas and the lack of implementing statutes at EU level. We prepare with our clients legally secure detailed solutions for the coming into force of the MDR on 26 May 2020. Through our work with associations we have been directly involved for years in legal development at European and national level.
Our expertise covers the structuring of contractual relationships within the supply chain and outsourced processes. This includes existing OEM/PLM cooperations. If necessary, we work closely with Regulatory Affairs advisors within our network.
Apart from businesses, namely manufacturers, importers, dealers and authorized representatives, our clients include universities, research institutions and associations which we advise on the regulatory requirements under the MDR and the IVDR. That also includes, of course, the area of clinical research and cooperations with industrial partners.
We focus specially on advising start-ups in medical technology which we support from the first product idea up to market launch; if necessary with the support of industrial partners.
We also advise clients on the form and conduct of clinical studies and legally secure cooperation with doctors and health institutions.
In cases of dispute, we advise and represent pharmaceutical companies in the defence of claims under the specific regulations of pharmaceutical law.
We support companies and research and health institutions in the structuring of cooperations, namely in the course of research projects, sponsoring or speakers’ contracts. We focus particularly on drafting clinical trials agreements between companies and scientific institutions (IITs, Investigator Initiated Trials).
In this regard, we support companies in comprehensive implementation of compliance structures.
Even at the early stage of research and development of products and therapies, important guides in the direction of product compliance must be observed. Not only clinical trials by industry companies but also scientific clinical research at universities and research institutions are increasingly legally regulated. That is also foreseeable for other (scientific/academic) clinical trials in the medical devices area with the coming into force of the new legal environment in May 2020.
We advise on the legally secure structuring of cooperation agreements between industrial companies and academic institutions with particular focus on IIT (Investigator Initiated Trials) agreements between industry partners and universities.
Not least, our expertise covers advising on clinical follow-up monitoring over the entire product life cycle.