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 EU IVDR for all IVD classes.
How important is it to work with an experienced consultancy company for IVDR file preparation? Hear from RQM+ Vice President of IVD Intelligence and Innovation and former BSI leader, Carlos Galamba.
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 EU IVDR, 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.
Learn more about IVDR regulatory submissions
Acquiring an existing IVD product line can overwhelm internal regulatory affairs resources, especially when steps are required to achieve compliance. We have you covered with established processes, procedures, templates, and tools to efficiently handle it all. We’ll take on due diligence, document remediation, product evaluation, labeling, manufacturing transition, and any other steps required for compliance, harmonization, and integration.
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.
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.
Listen to RQM+ Vice President of IVD Intelligence and Innovation and former BSI leader, Carlos Galamba, address the top IVD trends as of December 2021.