Experts RQM+ Bring IVDR Thematic Search Tool Free to Market to Help Increase Compliance Efficiency

Every day, regulatory, clinical, quality, and marketing teams at diagnostics manufacturers must refer to the EU’s upcoming In Vitro Diagnostic Regulation (IVDR). In order to make this process easier, a new, freely available IVDR filtering tool is being offered to the market by RQM+, the world’s leading medical device and diagnostics focused regulatory and quality consulting firm.

The tool has organized the IVDR by key themes and allows users to navigate the legislation using the subject areas most likely to be relevant to their day-to-day work.

Even though the MDR deadline was delayed to May 2021, the impending deadlines for the IVDR have not yet changed, so diagnostics companies remain under considerable time pressure to achieve compliance with the new Regulation to keep their products available on the EU marketplaces. Failure to comply on time could result in CE mark certification being withdrawn. Therefore, any ways to make regulatory preparation more efficient will benefit the whole diagnostics industry to participate effectively in EU markets.

Legislation is drafted to define legal responsibilities, rather than to provide optimum ‘searchability’ for Regulatory, Clinical, and Quality Assurance professionals. RQM+ has drawn on its wide-ranging and in-depth expertise to overlay IVDR with thematic metadata which categorises each section by fundamental compliance themes. Using this tool, regulatory, clinical, and quality teams can save considerable amounts of administrative time and concentrate their precious expert effort on professional workflows.

Providing this tool free, for the general benefit of the diagnostics industry, is the initiative of Nancy Morrison, RQM+ Executive Director, Regulatory & Quality Consulting Services. She notes, “There’s nothing more frustrating than to have to spend time searching through legislation to gather the key sections (or even sentences!) for each phase of regulatory compliance. That’s something I’ve even been told by regulators and notified bodies! Many colleagues across the sector have already been using our IVDR search tool, and we look forward to adding its MDR equivalent soon. In this way, our initiative can become even more worthwhile.”

The RQM+ IVDR Search Tool is available to download here.

The company is hosting a webinar. Details here.

SourceRQM+
Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides our readership with breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

The ArthroFree system is the first FDA-cleared wireless camera for arthroscopy and general endoscopy, both areas of minimally invasive surgery. The system is designed to help surgeons work with aximum dexterity and focus.
The project, which was led by the University of Southern California, included large increases in representation among men of African, Hispanic and Asian ancestries, that were contributed in part by an ongoing collaboration between the U.S. Department of Veterans Affairs and DOE reports Argonne.
This innovative software turns smartphones into medical-grade stethoscopes, allowing people to capture, analyze, and share critical heart health data with medical personnel from the comfort of any location notes Sparrow BioAcoustics.
"Taewoong Medical becoming an Olympus group company is also a major milestone in our global growth strategy," said Henry Shin, CEO of STARmed. "We look forward to our products being made available to more patients through Olympus' global distribution network."
The company reports they have successfully met the six-month primary endpoint for the first-ever female patient implanted with the UroActive™ System, the first smart automated artificial urinary sphincter (AUS) to treat SUI.

By using this website you agree to accept Medical Device News Magazine Privacy Policy