RQM+ employs global thought leaders who have dedicated their careers to IVD regulatory affairs and quality assurance. Our team understands how IVDs work, how performance is measured, and what type of documentation is required. With former regulators and notified bodies on staff, we have unique insights into what reviewers are looking for in your submissions.
We understand the reality that some IVD products are more profitable than others, which is why we take a business-balanced approach to providing strategic direction. We work with you to evaluate factors such as risk, market performance, and business goals, helping prioritize product updates and launches to meet evolving regulations and standards.
Our engineers and scientists have the technical and regulatory expertise you need on your team from the beginning when developing new products. Services include developing and updating regulatory strategy, aligning regulatory activities and business strategies, evaluating risk, providing regulatory review and input on product development documentation, and creating an efficient pathway to market.
The unrivaled collective knowledge at RQM+ allows us to provide expert support for IVD regulatory submissions, including FDA 510(k), PMA, IDE, EUA, breakthrough, and pre-submissions. Whether you need support for a single product, platform technology, or multiple product lines, we’re here for you.
RQM+ recognizes the vital role of quality systems for IVD manufacturers, emphasizing compliance with standards like ISO 13485 for regulatory adherence and product excellence. We prioritize risk management and continuous improvement, essential for mitigating potential hazards and enhancing products and processes. This commitment not only secures market access but also builds lasting trust with stakeholders, crucial for the sustained success of IVD manufacturers in the healthcare industry.
RQM+ has been at the forefront of the transition of the industry to in vitro diagnostic regulation (IVDR), with client-validated processes and tools to ensure compliance and keep your product(s) on the market. From strategy through detailed tactical execution, our expert implementers have experience in transitioning multinational organizations to IVDR for all IVD classes. Gap assessments, post-market documentation, and more are part of the suite of services we offer to get your products on the market and maximize your return on investment.
At RQM+, we offer specialized sustaining support for IVD manufacturers, ensuring their products consistently adhere to the highest standards of quality and regulatory compliance. Our services are tailored to the unique needs of the IVD sector, encompassing ongoing regulatory guidance, quality system optimization, and post-market surveillance. This focused approach helps maintain product integrity, ensures continuous compliance with evolving standards like ISO 13485, and supports the longevity and market success of IVD products. Our expertise in the IVD landscape positions us to effectively address the specific challenges and opportunities, providing our clients with the assurance and support they need for sustained growth and excellence.
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