We think in Medical Devices.
We support you in the creation of a clinical-regulatory strategy, process optimization and product development. For
- ■ business development
- ■ optimization of your product portfolio or
- ■ implementation of the MDR.
We provide competent answers to questions about product prioritization with portfolio analysis, market research and competitor analysis. In this process we carefully consider your ideas for product development, indications, claims, but also markets.
We have many years of experience in the medical device world.
Our offer is aimed at established medical device manufacturers and ambitious start-ups that want to enter this market. For all of these, the MDR (Medical Device Regulation, EU Regulation 2017/745) determines high requirements on the development and marketing of medical devices.
Companies that actively address the requirements have recognized that MDR is not only a regulatory compliance challenge, but also provides an opportunity to add value to the business through an enterprise-wide approach.
The existing product portfolio has to be checked critically for MDR compliance and changing market needs – including digitization. Throughout the product life cycle, clinical data must be proactively collected in the future. You can suitably control this process, e.g. by means of a clinical evaluation plan (CEP). The demands on clinical data and technical documentation have increased overall. Manufacturers are faced with enormous, sometimes completely new, challenges; not only in terms of personnel and finances, but also in terms of internal processes. Departments such as QM, Regulatory Affairs, Vigilance, R & D, Marketing and Finance are affected by changes. There is a need to develop a new clinical and regulatory strategy. Resources and stringent scheduling and prioritization will be essential due to the tight time frame for MDR implementation.
We also offer customised workshops for the development of a clinical-regulatory strategy and will gladly advise you on post-market follow-up measures and the detailed performance of post-market studies and clinical evaluations, as well as clinical trials.