Our global team has experience developing and optimizing quality systems that comply with ISO 13485:2016, FDA QSR, EU MDR, EU IVDR, MDSAP, and more. With certified and seasoned auditors on staff to provide on-site and remote audits, our team can identify and correct potential compliance issues before you get audited.
There is no one-size-fits-all quality solution for medical devices and IVDs. Our dedicated team will work with you to develop practical, right-sized policies and procedures for your team to follow. As an extension of your business, we develop your quality systems as if they are our own.
Whether your procedures are too cumbersome to follow or you just need to streamline your process, RQM+ is here with solutions. We’ll identify areas for improvement, map out effective processes and procedures to ensure compliance, and provide the necessary resources for implementation and training.
When an external audit results in nonconformities or a warning letter, you do not always have the internal resources to quickly and effectively respond. Our seasoned team of experts will support you with strategy, negotiation tactics, and leadership of remediation efforts.
The ever-changing regulatory landscape can leave manufacturers with many questions on interpretation and industry calibration. Our seasoned experts will conduct a gap assessment of the current state of your systems to determine the areas requiring compliance to the new regulations. With our unrivaled collective knowledge, RQM+ brings answers and best practice solutions.
Integrating an acquired company with new product lines into your business comes with a lot of moving parts, including updating quality systems. RQM+ understands how it all fits together. We provide support with remediation of any acquired compliance issues, in addition to quality planning for both short-term harmonization and long-term full QMS integration.
Learn more about Acquisition Integration