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 European Medical Device Regulations (MDR) places new requirements for clinical evaluation, basically putting the collection of clinical data in focus. Clinical validation typically takes a lot of resources from organisations developing medical devices. The scope of the evaluation as well as the requirements for the competence of the evaluators have increased significantly. In addition, the mere resource intensity has exploded to new heights. Manufacturers are required to execute extensive literature reviews, produce scientific/medical text, and complete complex risk management tasks also from a clinical perspective to fully complete the requirements of the MDR placed on the clinical evaluation of medical devices in all risk classes under the MDR. With the changing regulations combined with the growing lack of an expert workforce in the field, there’s an obvious gap between the needed effort and available resources in companies.
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 has 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. “At Innokas, we work with a wide range of quality and regulatory projects and customers in the Medtech field. We have clearly seen that clinical validation is one of the growing pain points for many companies. Even when organisations were familiar with the clinical evaluation process and had the necessary competence, the resource-intensity of clinical validation tasks surprised them,” said Satu Päiväläinen heading the new team at Innokas Medical.
The Innokas Clinical Affairs team combines several areas of expertise. “We can provide a wide range of support from basic clinical evaluation training to helping gather the necessary information and writing necessary reports. The team competence reaches from understanding the hospital environment, processes, and practices all the way down to understanding the impact of device use down to the cellular level. This broad competence also allows supporting our customers in biological safety evaluation. With this, we are well-equipped to help our customers to focus on their core tasks instead of the time-consuming clinical affairs,” explained Päiväläinen.
The new service fulfills the Innokas Medical QA&RA service portfolio and strengthens its one-location offering. The Clinical Affairs support will also be an integral part of the Innokas MDR Fast Track service.
Image (from left to right): Veera Hartikainen, Henna Halkola and Satu Päiväläinen.
Innokas Medical Oy
Source: Innokas Medical