OUR TEAM

Meet Our Experts

Our team of regulatory consultants is dedicated to providing top-notch consultancy services. With diverse backgrounds and a shared passion for regulatory excellence, we collaborate to deliver exceptional results.

Maria Manfredi

CHIEF REGULATORY AFFAIRS CONSULTANT

Accomplished regulatory and quality leader with 13+ years of experience guiding Class I–III medical devices through global market access and compliance. Proven success in developing regulatory strategies, leading complex submissions, and building Quality Management Systems aligned with FDA, EU MDR, and international requirements. Adept at translating regulatory frameworks into practical solutions that enable timely approvals, sustain compliance, and support business growth. Recognized for leading cross-functional teams, managing audits and site transfers, and serving as a trusted liaison with regulatory authorities worldwide.

CORE COMPETENCIES

· Global regulatory expertise for Class I–III medical devices (FDA, EU MDR, Health Canada, ANVISA, TGA, PMDA)

· Regulatory strategy, submissions, and lifecycle compliance (510(k), EU Technical Documentation, GSPRs)

· QMS implementation, maintenance, audits, and gap assessments (ISO 13485, 21 CFR 820, MDSAP, ISO 14971)

· CAPA, document control, and post-market surveillance (PMS Plans/Reports, PSURs, PMCF, risk management)

· Clinical Evaluation Reports (CERs) and systematic literature reviews · Risk-based sterility, safety, and compliance assessments

· Post-Market Clinical Follow-up (PMCF) planning, SSCPs, and benefit–risk analyses

· Project management and cross-functional team leadership

· Lean Six Sigma Yellow Belt

· Change management and stakeholder engagement across global teams

· Direct engagement and advocacy with regulatory authorities and Notified Bodies

Vinitha Kethi

SR REGULATORY CONSULTANT

A seasoned Medical Device Regulatory and Quality professional with over 4a decade years of specialized experience in Post-Market Surveillance (PMS) and EU MDR/FDA compliance. They hold an MBA in Data Analytics and a Master’s in Biomedical Engineering, making them an expert at synthesizing complex clinical data into regulatory technical files.

Core Competencies

Regulatory Mastery: Extensive experience with EU MDR (2017/745), MDD, and FDA 21 CFR 820. Expert in Class IIa, IIb, and III device classifications.
Technical Documentation: Proven track record authoring and remediating CERs, CEPs, PSURs, PMCF plans, and SSCPs for Notified Body submissions (BSI, DEKRA).
Quality & Risk Management: Certified ISO 13485:2016 Lead Auditor with expertise in ISO 14971 risk-benefit assessments, CAPA management, and 510(k) remediations.
Data-Driven Analysis: Skilled in systematic literature reviews, signal detection, and trend analysis using Minitab and Six Sigma methodologies to ensure patient safety and product performance.

Elizabeth Rose

CHIEF REGULATORY CONSULTANT

Over 27 years of experience in manufacturing, regulatory, and quality for the medical devices industry, coupled with Master of Science in Technology that is focused on Quality Assurance. She has honed her expertise in advising on pre- and post-market U.S. and regulatory requirements, as well as regulatory requirements in the Rest of the World (ROW).

She has authored and submitted over 40+ 510(k) submissions, and have successfully submitted EU MDR Technical Documentation Submissions and MDR Significant Change Notices.

Her experience includes preparing U.S. Class III Annual Reports, PMA Amendments, PMA 30-Day Supplements, and Change Determinations for Hyaluronic Acid injectables intended for ophthalmic, orthopedic, and some veterinarian indications.

In the CMC department, she has managed the preparation of NDA and ANDA Annual Reports and PADERS.

With over 20 years of experience in STED document and requirements, she has implemented these documents at various organizations to expedite global registration timelines.

She has not only compiled STED documents for registrations but has also assisted companies in adopting the format to enhance registration efficiency.

Her expertise extends to reviewing and approving Advertising and Promotional materials for class I, II, and II medical devices, adhering to IFPMA guidelines, the FD&C Act, 21CFR, 21 USC 352, the FTC, GPR 10136, GTS 50079, and other global requirements. She collaborates closely with Marketing, Medical Affairs, Sales, and Educational Subject Matter Experts (SMEs) to ensure compliance.

She has extensive experience in writing and reviewing clinical evaluation reports (CERs) for various medical devices across different therapeutic areas. Additionally, she stays updated with the EU Medical Device Regulations and In-Vitro Diagnostic Regulations.

She has owned, investigated, trained and implemented CAPAs following Notified Body audits, internal audit findings, developing risk management strategies, writing procedures, and supporting the design history files.

The therapeutic areas of expertise include orthopedics, dental, wound care, oncology, imaging, general and plastic surgery, electrosurgical, ultrasonic, cranio-maxillio facial, ophthalmic, cardiovascular, gastroenterology, ENT, urology, gynecology, bariatrics, respirator, IV sets, and sutures.

ABOUT

RegMed Support

RegMed Support is a regulatory consulting firm specializing in the medical device industry. We offer a comprehensive range of services including product development and design support, compliance assessments, regulatory gap analyses, 510(k), IDE, and PMA submissions. Our team assists clients with navigating regulatory compliance for FDA, EU, Health Canada, and other global regulatory authorities, as well as conduct compliance audits and provide quality management systems support. RegMed Support aims to attract new clients and stands out through its exclusive focus on the medical device sector, boasting consultants with decades of real industry experience to ensure product safety, effectiveness, and compliance with global standards.