The MDKT manages your MDD-MDR transition process!

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Clinical Evaluation strategy

Based on your Preclinical and Clinical data we can identify strength and potential pitfalls in your existing data on clinical performance and safety for operators and patients. Given your marketing ambitions a solid forward-looking Clinical Evaluation strategy will be developed to bridge the current gaps and guide you to future goals. It will incorporate the stages of Clinical Evaluation to be completed, evidence to be found, scope and approach to get through the MDR transition.

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Updating and/or development of the Clinical Evaluation Reports

Clinical Evaluation Reports updating and/or development comprises upgrading of all pieces of information as per MDR. All claimed indications for use will be reviewed, clarified and refined in order to be accepted by the notified bodies. Literature searches will be done subsequently to have a systematized understanding of the current status of the device in question and a context in which it is placed. Clinical Investigations data documented is reviewed and systematically reported considering their grade of compliance. Lifetime data and the respective plans will be outlined for the medical device in question. Given State of the Art presenting for your submission and complying with General Safety and Performance Requirements, the Benefit/Risk conclusions will be based on the documented quantified clinical benefits for various indications and adverse events.

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Clinical Evaluation Planning

Depending on the identified gaps The Clinical Evaluation Plan is a roadmap for conducting the clinical evaluation process. It includes the scope, methodological, and systematic approach on how to proceed and reach a conclusion on the clinical evaluation, to document it in a Clinical Evaluation Report. We ensure that every Clinical Evaluation Plan developed by us complies with the respective ISO standard and Annex XIV of the Medical Device Regulation. As well, we are ready propose you several different study designs to concurrently cover your needs and to fit your budget.

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Performing Clinical Studies

As a full-service CRO we can perform for you a Clinical Study on a turn-key basis. If agreed so, any accompanying tasks concerning a Clinical Study outsourced to us will be accomplished. In a close cooperation with you as a Sponsor we can provide you with all services starting from Clinical Evaluation Planning and to Clinical Evaluation Reporting in line with all applicable regulatory requirements. Moreover, as Clinical Studies conducted in Ukraine in line with the regulatory requirements are acceptable for the MDR submissions, you may enjoy numerous advantages e.g., cost saving, reduction of the length of submission to the notified bodies, shorter enrolment period etc.

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Clinical Data Reporting

The transparent Clinical Data reporting focused on the Study objectives is crucial for the MDR submission. The highly user-friendly Electronic Remote Data Capture System Online CRF is consistently used by us to collect and organize complete and clean clinical data. This approach allows our client to be confident that the Clinical Data collected gives a reliable prospective on the clinical performance and safety of the Investigational Medical Device. What is more, electronically stored data can be then reformatted for the ease of reference, pulled and repeatedly analysed to support a subsequent clinical development.

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Post-market surveillance

If your medical devices have been placed on the market, the Post-market surveillance is a must to collect and evaluate experience gained from medical devices and to identify the need to take any action. Even though your medical devices are proved to be safe and well-performing, the post-market surveillance is the only way to ascertain that your medical devices remain to be so. Moreover, the Post-market surveillance in place guarantees that the measures can be undertaken if the risk of use of the medical device exceeds the benefit. The Post-market surveillance also reveals opportunities to improve the medical device.