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RQM + creates a filtering tool that facilitates MDR navigation




RQM + has created a tool that allows users to search for laws in a particular subject area, facilitating navigation of EU Medical Device Regulations (MDRs).

Most regulatory and quality professionals can think of times when it was difficult to find specific requirements in MDR. Finding all the instances that mention a particular compliance theme can be a daunting task.

Corporate internal specialists and regulatory professionals within client companies can save daily administrative time by browsing regulations using tools. You can use this tool to search by topic, chapter, article, and search term. Instead of highlighting or pasting a copy of the paper, users can save notes about the company’s interpretation of the MDR section and the individual statements of the tool itself.

Regulatory and quality consulting firms are already sharing IVDR filtering tools to support manufacturers working towards the EU’s upcoming in vitro diagnostic regulation (IVDR). Both IVDR and MDR tools are now available for download by medical device professionals to discuss their daily work.

You can see a demo of the RQM + MDR filtering tool here.

Dr. Jaishankar Kutty, Vice President of Clinical Services at RQM +, said: MDR review on BSI! More than any other stakeholder, the notifying body needs to know the regulation inside out, and this tool makes it easy to reaffirm your requirements. Now located on the desktop for easy access, it’s been a very useful and welcome support so far.

Nancy Morrison, Executive Director of Regulatory and Quality Consulting Services, first developed these tools to support the RQM + team.

She states: As we refer to regulations on a daily basis, we are fully aware of the frustration of trying to find specific details or collecting all sections that mention the area of ​​compliance. rice field. We help our clients implement a clear and organized process to promote short-term and long-term compliance. We hope that these tools will make the work of regulatory professionals a little easier.




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