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»» EU Regulation calls for major changes in the medical technology industry
»» A major challenge for small and medium-sized enterprises
TRACOE medical GmbH is rigorously preparing for the implementation of the Medical Device Regulation (MDR), which definitively enters into force in May 2020. In addition to this, TRACOE has initiated two major programmes, which will ensure MDR compliance by May 2020. There are good reasons why the company is making this effort: “The new regulation involves the industry’s most drastic change in decades - presenting tremendous challenges, especially for small and medium-sized enterprises, because the regulatory expense is so high that there is a risk this will present insurmountable hurdles for niche products and, in particular, for small medical technology manufacturers”, TRACOE medical GmbH’s Managing Director Dr Thomas Jurisch explains. “And as these are our core issues and we intend to position ourselves optimally for the future, we have made the conscious decision to implement the new regulations as quickly as possible”.
TRACOE already started planning for the MDR a year ago and, following the successful audits in May, is now implementing the specified measures within the framework of two major programmes. By application of the MDD (Medical Device Directive), the company concluded the European Medical Devices Directive currently in force. It also provided services in accordance with the regulations for EN ISO 13485:2016, which governs the requirements for a comprehensive quality management system for the design and manufacture of medical devices. TRACOE medical also completed the MDSAP (Medical Device Single Audit Program), making the cannula manufacturer the first company to be certified by the competent team of auditors.
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