Innokas Medical strengthens its QA&RA services with a new Clinical Affairs team. The new team supports medical device companies in carrying out resource-binding clinical evaluation related work by providing the needed resources and know-how for the companies.
The changes in Clinical evaluation requirements are one of the big changes brought on by the implementation of the MDR on the 26th of May 2021. These changes affect not only the newcomers in the field of medical device development but also all the manufacturers that were already operating in the field in the EEA during the Medical Device Directive times. Many of the existing medical device manufacturers are taking advantage of the transition period offered by the MDR, but also that will come to an end on 26th May 2024, after which all devices made available on the market must be certified under the MDR.
The changes in the clinical evaluation requirements affect many areas in it. For example, the scope of the evaluation, as well as the requirements for the competence of the evaluators, has increased significantly. In addition, the mere resource intensity has exploded to new heights. Manufacturers are required to execute extensive literature reviews, produce detailed scientific/medical text and complete complex risk management tasks also from a clinical perspective to fully comply with the requirements the MDR places on the clinical evaluation of medical devices in all risk classes.
Innokas Medical has been helping our existing customers with their needs regarding Clinical Evaluation and Clinical Investigations already for a few years. As the direct demand for the service has grown and is constantly growing further, so does our team of clinical specialists. Now finally, with the strength of 3 people, we are ready to tackle clinical evaluation and investigation related needs for new customers instead of providing the service only to our existing ones.
Our clinical team competence is built on both scientific know-how and healthcare experience. Together we can not only understand exactly how devices take effect in patients, but also identify the possibilities and risks related to their use in different healthcare environments. With this broad combined competence backed up by the whole extensive Innokas QARA team, we are confident in our ability to not only guide our customers through the demanding clinical evaluation process but to actually harness its force to the benefit of their design and development. In addition, with the competence of the whole Innokas team, our clinical specialists have the ability to gain an understanding of different technologies and their pressure points from the regulatory point of view, allowing us to be open to the needs of any type of product on its way to the market.
Want to know more about what makes us different?
Contact Satu Päiväläinen, satu.paivalainen(a)innokasmedical.fi