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Graywolf Research Group has been the leader in the progress of the business to in vitro diagnostic regulation (IVDR), with client-approved tools and processes to guarantee consistency and keep your product(s) available.
Our researchers and engineers carry the regulatory and technical expertise you want in your team from the very start while developing new products. We work with you to assess factors like business objective, market execution, and risk.
From strategic planning through detailed execution, our implementers have first-hand knowledge and experience in progressing organizations to EU IVDR for all IVD classes. We take care of you with established techniques, procedures, and tools to deal with it all productively.
Services incorporate providing a regulatory review, input on product development documentation, aligning regulatory activities, and business strategies, developing and updating regulatory strategy, and evaluating risk.
