Our service includes a comprehensive consultation to help identify priorities and potential paths to success. The next step is up to you: assistance with writing that pre-submission, design dossier, or PMA; assistance with that annual CER update; another set of experienced eyes on your draft regulatory submission; a comprehensive global regulatory strategy plan with rough costs, timelines and milestones; or even just ongoing strategy sessions as conditions or priorities change. We believe that what is critical is ensuring you are prepared for whatever changes or new requirements may come along so you can still reach your goals. 

If you're looking to file that pre-submission to get some FDA buy-in on your regulatory plan or you're ready to file that last module of your PMA, Metrowest Regulatory Associates are here to help.  From 510(k)s to Request for Designations and from IDEs to PMAs, we have the experience to assist.

From streamlining those international submissions to revamping your design dossier, Metrowest Regulatory Associates can help you on your way.  Like most of the medical device industry, Metrowest is waiting and anticipating the date of full implementation of the new Medical Device Regulations in Europe, and we're here to help get your dossiers and clinical evaluation reports ready.