Experienced medical device regulatory professional providing concept-to-market consulting services for medical devices and in vitro diagnostics (IVD).

Key areas of expertise:
+ Providing training services to organizations to be a robust medical device/IVD manufacturer
+ Identification and decision-making support for regulatory strategy and due diligence
+ Interactions with regulatory authorities (US FDA and Health Canada) at various levels of engagements
+ Regulatory Submissions
+ Full service support on 510(k), PMA, IDE, De Novo Submissions, CLIA Waiver Applications, Pre-Submissions, Submission Issue Requests, MDELs
+ Submission content review and compilation
+ eSTAR and Pre-STAR applications
+ Labeling reviews
+ Support review process to resolve submission deficiencies
+ Regulatory Project Management/Program Management