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EU MDR and IVDR have changed the business, and numerous manufacturers are striving to refresh their frameworks. The clear integration of PMS, CERs/PERs, and risk management is basic for meeting body expectations and keeping products available.
Graywolf Research Group has broad expertise in effectively integrating these frameworks to help business operations ideally.
We help worldwide manufacturers execute procedures and strategies for composing clinical/performance evaluation and post-market surveillance plans and reports for medical devices and diagnostics (CEPs, CERs, SSCPs, PEPs, PERs, SSPs, PMS Plans and Reports, PSURs, PMCF, PMP).
For some manufacturers, having r audit and submission-ready CERs and PERs is on the critical way to certification, and these documents are supposed to meet intense surveying by the notified bodies. We will create and execute techniques and processes that enhance efficiency for your team and have you prepared for MDR/IVDR certification.
Whether for specific projects or all things regulatory, add capacity to your internal team for assigned product lines with our subject matter expert support.
