You may already have experienced the challenges of developing medical device products. And you may be aware of the large changes in the regulatory landscape that have arrived with the Medical Device Regulations (MDR 2017/745) and the In Vitro Diagnostics Regulation (IVDR 2017/746). There are regulations that have replaced the directives (93/42/EEC, 90/385/EEC and 98/79/EC). Or you may not. Whatever your situation, we can help you reach your destination.
In the MDR, there is a clear emphasis on clinical evidence, which may be perceived as a new mind-set. And the focus is not only clinical evidence per se, but also the quality and the validity of the clinical data for the product at hand. For a manufacturer it makes it even more important, and potentially challenging, to set up and execute appropriate clinical development and evaluation plans. The goal is to generate solid and robust data that supports the claims on performance and safety.
In a sense this means that success in medical device product development is partly measured as an ability to interpret the landscape and develop an appropriate map for navigation. The landscape not only involves the regulatory requirements but also the market into which you want to enter. Strategic decisions for your clinical program based on thorough understanding of all the above are some of the most important success factors in the life science business. Getting it right from the start is critical.
SCRO can provide you with support in the interpretation of the regulations for your particular product(s). What does it mean for you? We can support you early on, when you are working with your target product profile (TPP), defining the intended use and future claims. When you are thinking about the state of the art. We have experience in clinical evaluations (as per MEDDEV 2.7/1 rev 4) and the activities that are a part of that: literature searches, analyses and appraisals of your data, as well as data publicly available data. And we can help you plan, execute and document your clinical studies. Please contact us to discuss your needs.