ISEK – Istanbul Health Industry Cluster – Accrediated Test Labs & Sectoral Database Work Package (2019)

    About the Project

    ISEK – Istanbul Health Industry Cluster is a collaboration of various industrial companies with the related university research centers, public institutes and NGOs in health market in Istanbul Region. ISEK  comprises 200 firms, 22 universities (relevant research centers) and 14 NGOs. The cluster has been funded by Industry and Technology, Clustering Support Program between 2017 and 2022 with the coordination of Technopark Istanbul. Pronish provided consultancy in Accredited Test work package for ISEK programme.

    Concrete Outputs as Consultant

    • Identification and assessment of the urgent needs of local medical device manufacturers in bio-compatibility test criteria based on ISO 10993 standards to help the transition to the new EU Medical Device Regulation (MDR)
    • Gap analysis in accredited test capabilities of the existing ecosystem in Turkey to prepare an action plan to prioritize the completion of the deficiencies and accreditation of the existing laboratories for fulfilling the new MDR requirements
    • Project Management of the creation of sectoral database for the testing needs of local manufacturers, and conductance of a detailed data analysis in Product Tracking System (UTS) of Ministry of Health (MoH) on the registered medical devices of the local manufacturing exporting companies based on the classification of these to better determine the transition strategy of the respective products of the manufacturers with product focused approach
    • Preparation of an action plan proposal for rapid improvement of the accredited bio-compatibility testing and analysis services in short term as a national-scale pioneering initiative by using finding of the created database showing the needs and potential solutions to gain the support of MoH for speeding up process addressing the identified gap and challenges of the local manufacturers in ISEK and Turkey.
    • Supported the working group under the coordination of Marmara Medical Device Manufacturers and Suppliers Association (MASSIAD) to examine and elaborate the changes brought by new MDR in details and create a roadmap for the medical device industry.