Medical devices represent an increasing share in the healthcare market, whether they are medical devices for professional use or consumer care.
Regulatory requirements were significantly tightened in 2017, with the adoption of Medical Devices Regulation (EU) 2017/745 and IVD Regulation (EU) 2017/746.
Salus Cons Kft. offers to its clients the service of creating a complete technical file according to both regulations, including clinical evaluation (for medical devices) and performance evaluation (for IVD devices).
We have experience in all areas of medical devices, including substances and combinations of substances, active medical devices, software as a medical device, sterilization, packaging validation and more.
We create a plan and report for biological evaluation, and if a biocompatibility test is needed, we help clients choose an accredited laboratory.
If it is necessary to conduct a clinical trial or a performance trial, we have experience in the preparation and implementation of these trials, in accordance with the requirements of EN ISO 14155:2020 and the Regulations. Our service includes:
- Development of study protocols
- Creating a brochure for the researcher
- Preparation of written patient consent
- Statistical activities (sample size planning, statistical method planning, statistical calculations upon completion of the study)
- Monitoring
- Writing a clinical evaluation report
We run companies throughout the development process (recommended) or get involved at the time of preparing the technical documentation. If the medical devices concerned are higher class, we help the client with choosing a notified body and guide them through the process of obtaining an EC certificate.