We turn to you as to a producer of medical device, as the 2017/745 EU (MDR) regulation will be effective by 26th May 2021 at the economic area of the European Union, in a further year the 2017/746 (IVDR) EU regulation will bring important novelties in the regulation of conformity of medical devices. The preparation for the mandatory certification requires substantial time and attention due to the renewed, strict European regulations, both in case of existing and new products. The imminent change is of major importance for the producers, importers, health institutions, patients and operators. The new regulations implicate first of all a clearly stricter professional control, but mostly higher safety for the users on the other hand. In order to support the professional preparation for the new conformity requirements we launched QTICS MEDICAL with the association and cooperation of CCLab Kft., ConformiTICs Kft., DRC Kft., SAASCO Kft., TAM CERT Kft. and TOXI-COOP Zrt., which companies have been engaged, familiar and well known in their respective disciplines for the medical service market.
The specialty of QTICS MEDICAL is the ability to provide its Clients a fully-fledged portfolio of services, so that they can manage their complete conformity assurance process, starting with consultancy, going through different tests and necessary validations. The needs of the various economic actors of the medical device manufacturing and /or import tend to be typically different, therefore any of the below service field and elements can be taken individually or in the appropriate combination with each-other:
- The primer item of the integrated service value chain is the thorough and substantive consultancy, expertise, and professional education.
- Another fundamentally important element for the producers of medical devices is the implementation and certification of their manufacturing quality management system by MSZ EN ISO 13485:2016, as required by MDR as well.
- The devices themselves must pass strict safety and usability tests, done in our accredited testing laboratories. Further requirements are raised by the pre-clinical tests, like biocompatibility and toxicology tests, further by the mandatory clinical validation, and the regular and documented post-market entry monitoring activity.
- Regarding the extended MDR/IVDR European regulations the new requirement of a cybersecurity evaluation of active medical devices and software appears as well! This is provided by our specialized, internationally accredited cybersecurity evaluation laboratory.
- Finally, we manage as planned all the necessary steps and stages of our Client’s preparation for the product certification (CE-Marking) as an integrated project, with dedicated expertise, in case you assign this to QTICS Medical.
The conformity assessment and the certification shall be performed by the independent Notified Bodies, officially registered by the European Commission. They can be reached at the following links:
QTICS Medical will provide all steps and services relevant for the conformity assessment and the successful certification, we shall lead you through the entire project! Though we created this complex service chain primarily for the producers/importers of active and IVD medical devices, many of the service components are available also for the manufacturers and importers of the non-active medical devices as well. Such services are consultancy, education, expertise, the introduction of a quality management system, biocompatibility tests, clinical investigations. With regards to the strict nature of the European regulations, the preparation for the certification requires substantial time allocation, care and dedicated work. The certification of the prevailing products in compliance of the new regulations is a duty, it is obviously evident and a must for the new products.
Compliance with the regulation of medical devices poses an increasingly difficult task for economic operators. In order to reduce the burden on economic operators, we provide full support for the CE marking of medical devices (MDR & IVDR), from regulatory strategy to post-market surveillance.Read more
Fulfilling the requirements of CE marking is inconceivable without acquiring the appropriate knowledge. We provide training in all relevant areas related to CE marking of medical devices in the form that best suits your needs: open and outsourced or customized training.Read more
The entrance ticket to the international medical device market is an ISO 13485 certification. With our accreditations for ISO 13485 and ISO 27001, we provide internationally recognized certificates. In addition, we support our Clients throughout the certification stage with a Notified Body.Read more
Active and IVD devices which are connected, store any data, include any computing, control analog or digital functionality are subject to mandatory assessment and validation of cybersecurity risk. We execute cybersecurity evaluations based on the strictest accreditations and standards.Read more
One of the keys to CE marking of medical devices is the validation of clinical safety and performance. With our team of doctors and biologists, we provide a full range of services from the design of clinical investi- gations, through the licensing to the preparation of a clinical investigation report.Read more
Safety & Preclinical testing
Verification of medical devices safety is mandatory for all manufacturers. We provide safety tests according to IEC/EN 60601 and IEC/EN 61010 standards series, biocompatibility tests according to ISO 10993 standards series and usability testing and evaluation according to IEC/EN 62366-1 to verify the basic safety and the essential performance of active medical devices.Read more