Our global team is comprised of engineers and scientists who understand how medical devices, IVDs, and combination products work, how performance is measured, and what type of documentation and evidence is required. With former regulators and notified bodies on staff, we have unique insights into how regulatory bodies and reviewers are likely to respond.
The unrivaled collective knowledge at RQM+ allows us to provide expert support for regulatory submissions, including EU MDR, FDA 510(k), PMA, De Novo, IDE, EUA, breakthrough, and Q-submissions. All clients benefit from our systematic approach to sharing information and knowledge while also ensuring client confidentiality.
RQM+ has expert implementers with experience in transitioning multinational organizations to EU MDR for all device classes. From strategic planning to tactical execution, we apply our client-validated transition processes, procedures, and tools to acquire or maintain CE marking and keep your product on the market.
Learn more about CE Marking
Our engineers and scientists do more than review and compile data—they play an active role in new product development teams from the beginning. 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.
Acquiring an existing product line can easily overwhelm internal regulatory affairs resources that are already fully allocated. The seasoned experts at RQM+ can handle due diligence, remediation of documents, product evaluation, labeling, manufacturing transition, and any other steps required for compliance, harmonization, and integration.
Companies with multiple product lines typically do not have the capacity to handle all aspects of regulatory affairs simultaneously. We balance regulatory risk with your business goals to provide strategic direction on complex regulatory challenges and help you prioritize product updates and launches to meet evolving regulations and standards.
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