Who We Are

25 years regulatory affairs experience, including:

• IVD Devices (including LDTs and Companion Diagnostics), Medical Devices and Combination Products
• Formulating, evaluating and executing regulatory approval/clearance/registration strategies 
• Pre-Submission document preparation
• Preparing and leading Pre-Submission and submission review meetings with FDA 
• Successful 510(k), IDE, PMA, BLA and MAA submissions
• Successful Class III Design Dossiers for CE Mark
• Approval and Class II and III CE-Mark renewals
• Global product registrations (new and renewals)
• Extensive experience with agency interactions in the US (FDA – CDRH, CBER) and EU (EMA, Notified Body)
• In depth knowledge of US Medical Device and IVD regulations (CLIA, LDT, Companion Diagnostics), 510(k), IDE, PMA, Combination Product regulations; EU Regulations (MDR 2017/745), (IVDR 2017/746), and global medical device/IVD standards and requirements (EN ISO 10993, EN ISO11137, EN ISO14971, ISO15223, ISO13485, etc.)
• Designing, reviewing and approving clinical test plans, protocols, and reports in support of FDA 510(k), IDE, PMA and BLA submissions for IVDs and Medical Devices
• FDA and Notified Body audits; MDSAP audits
• Reviewing and approving labeling, marketing collateral, and customer communications for compliance to regulatory requirements

 17 years regulatory affairs experience, including:

•  Authored over 175+ US submissions (510(k)/IDE/PMA submissions, supplements and reports). 
• Experienced with IVD medical devices, medical devices and drug/device combination products
• Specialty areas include:  in vitro diagnostics (IVDS), laboratory developed tests (LDTs), companion diagnostics (CDx), cardiovascular devices, vascular devices, neurovascular devices,), drug/device combination products, injection devices, AI-based capsule endoscopy analysis software, SaMD, cybersecurity, RF microneedling devices, medical imaging devices, orthopedic devices, spinal devices, sterilizers, endoscopes, intraocular lenses, viscoelastics, dental devices, human tissue products, blood filtration devices, automated endoscope reprocessors.
• Wide range of negotiation skills -- from brainstorming with FDA on early product development strategies for new technologies (breakthrough devices) to negotiating approvals for line extension 510(k) and PMA devices.
• FDA Q-submissions; 510(k)s (including eStar format); IDEs and PMAs; de novos; FDA breakthrough designations
• Experienced with developing and leading early feasibility, feasibility and pivotal FDA IDE clinical trials
• FDA Type B & C meeting requests/meetings for breakthrough drug-device combination technology program; 
• SOP and WI development
• Authoring EU MDR technical documentation (TD) files, clinical evaluation reports (CERs) and medicinal dossiers.