➡️ Strategic Consulting ⬅️

A key factor for success in the development of a new Medical Device is identifying the optimal pathway from proving safety and efficacy, gaining EU market approval right through to reimbursement.
With the implementation of the new Medical Device Regulation (MDR), the updated EN ISO 14155 and its associated requirements, entering the EU market can be a real challenge. TRIQ has the expertise and competence to advise and support you in launching and placing your Medical Device in the European market efficiently and cost-effectively.

➡️ Feasibility Assessment ⬅️

TRIQ senior consultants have experience and expertise in dealing with Notified Bodies and Competent Authorities.
We can advise you on a clinical trial design that is required to prove your safetey, efficacy and identify CE-Marking requirements.

➡️ TRIQ Services we offer ⬅️

– Cooperation with EU Notified Bodies for all certification requirements
– Support with Medical Device classification
– Review of- and Support for your technical files and design dossiers
– Clinical Evaluation Report (CER) and Literature Report (LR) according to MDCG and MDR
– Literature reviews
– Post market surveillance plans and reports
– Post-market clinical follow-up plans and reports
– Periodic Safety Update Report (PSUR)
– Summary of Safety and Clinical Performance (SSCP) and other regulatory reports
– Clinical Evaluation Plan (CEP)

➡️ TRIQ Marketing Support ⬅️

TRIQ has decades of experience in the medical devices industry, at all levels of complexity and applications. Our team of experts can assist you to prepare for the post trial positioning and market entry of your Medical Device with all the prerequisites to be successful including reimbursement of your Medical Device.

Contact us so that we can discuss your individual needs.

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