MDRA Solutions provides regulatory affairs consulting to medical device and IVD companies mainly focused on the international markets such as LATAM, APAC, ASEAN, and EMEA. We assist with medical device registration/approval, renewals, change notifications and regulatory strategy. Also, we help with EU MDR STED and technical file/design dossier development, maintenance and remediation.
For more information, email [email protected]
Company’s Keywords:
preparation & submission, international regulatory registrations, design dossier, medical device & ivd registation, regulatory affairs submission strategy & compliance, regulatory affairs education, medical device, dossier review, regulatory assistance, technical files, international regulatory affairs, global regulatory affairs
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