RQM+ is here to help you develop the best possible devices so you can stay competitive. We provide as much or as little support as you need, including design document review, risk management file creation, design review support, and defect/anomaly assessment.
Our DQEs have the unique ability to analyze risks and provide you with multiple pathways so that your team has the freedom to innovate. No matter how large or complex the project is, we can come up with multiple solutions that encourage creativity while also protecting patients and ensuring compliance.
The new MDR and IVDR requirements impact products that have already been on the market, and it may be especially challenging to bring legacy devices into compliance. If your design history files are incomplete, we can provide a detailed gap analysis that highlights the areas that need the most work.
If your team doesn’t have the capacity, our expert implementers can either guide your team through the file remediation process or handle it for you. We provide SME support for all functions, including risk management, standards compliance, biocompatibility strategy, hazardous substances, clinical evaluations, labeling and unique device identification (UDI), supplier quality, and economic operators.
We know how to optimize your design history files because we have decades of experience with regulatory agencies and notified bodies. Our team has prepared hundreds of technical documentation and design history files for global clients. Every reviewer response has been fully assimilated into our systems to grow our collective knowledge and continually improve our processes. We also maintain a deep network to keep an eye on trends and evolving best practices in the industry.
We get your products and your business.
RQM+ does more than provide expert design quality engineering services for medical devices and IVDs. We act as a strategic partner that has your business goals in mind with every step we take.
Yes, if its not a concensus standard, its not recognised by FDA and therefore is the standard that you need to show conformance with. However FDA understands that newer versions of the standard may be utlized and tested to. FDA will expect to see in your submission an explanation of the differences bewteen the versions of the standards and why your evidence is applicable to the consensus standard.
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