MedTech Regulatory Considerations 101: Lunch & Learn with RQMIS

Are you an innovator or entrepreneur working on a new medtech solution or innovation? Attend this first half of a lunch & learn series with RQMIS to learn about the nuts and bolts of the medtech regulatory process. Topics covered include reulatory path overviews, presubmission strategies, insurance reimbursement, and quality managements systems. These topics will lead into the second half of the lunch & learn on October 24th that covers pre-clinical testing, clinical testing, cybersecurity, and navigating regulatory submissions. Don't miss this in-person, free oportunity to gain valuable insight into the medtech regulatory process, network, and enjoy free lunch.

Biomedical engineer (with a chemical engineering concentration) with MBA having 24 years experience in regulatory/clinical/quality affairs for medical device/biotech companies. Seven years experience as a Biomedical Engineer and Sr. Scientific Reviewer at FDA/CDRH/ODE and FDA’s Boston District. This government experience was followed with seventeen (17) years in midlevel and executive management positions in small start-up and large multinational medical device companies. Market responsibilities included United States (including Puerto Rico), European Union, South America, Canada, Japan and South Korea.
Experience includes regulatory submissions (510k, IDE, PMA, HUD/HDE, Design Dossiers), Clinical Study Design/Management, Risk Management, Quality System Design/Audits (FDA QSR and ISO 13485) and FDA Negotiation and Communication (QSR Audits, 483s, Warning Letters, Bioresearch Monitoring, Medical Device Reports, Recalls).
Provides companies with regulatory and clinical strategic advice on bringing novel technologies to the United States and EU markets in the clinical fields of orthopaedics/neurosurgery/diabetic care (spine, restorative/reconstructive, sports medicine and wound healing), gastroenterology/urology/gynecology/pulmonology/cardiology/plastic surgery (endoscopy/laparoscopy/minimally invasive/biliary stents). The devices involved have included active implantables, long term implants, electromechanical, ultrasonic imaging and PACS products.

Our vision is simple: To be the provider of choice for the development and implementation of regulatory and insurance strategy by utilizing the most efficient and effective commercialization pathway to medical product markets across the globe, including designing the quality system that brings the product to life. When these pathways demand clinical evidence to validate that a product is safe and effective, whether it is for publication, insurance reimbursement or regulatory approval, RQMIS provides our customers with complete support for the entire product lifecycle.

Since 1996, RQMIS has been providing manufacturers in the medical and healthcare industries with strategic guidance on how to effectively navigate the FDA and EU regulations. Our consultancy is focused primarily in four areas: Regulatory Strategy and Submissions, Clinical Study Design and Management, Quality Systems Design and Compliance, and Insurance Reimbursement. Our headquarters is located in Boston, MA and we have two additional locations in London and Barcelona.

12:00 PM – 12:10 PM: Welcome and Introductions

• Brief introduction to RQMIS and its role in the medical device, pharmaceutical, and nutraceutical

industries.

• Overview of the Lunch and Learn objectives.

12:10 PM – 12:25 PM: Understanding the Regulatory Pathway

• Key steps in navigating the regulatory landscape for medical devices and pharmaceuticals.

• Overview of the FDA and international regulatory requirements.

• Common challenges and how RQMIS supports clients through the process.

12:25 PM – 12:40 PM: The Importance of Presubmission Strategy

• Introduction to the FDA’s Q-Submission program.

• Benefits of early interaction with regulatory agencies.

• How to effectively prepare for a pre-submission meeting.

• Case studies on successful pre-submission strategies.

12:40 PM – 12:55 PM: Navigating Insurance Reimbursement

• Overview of the insurance reimbursement process for medical devices.

• Strategies for securing coverage and reimbursement.

• Understanding coding, coverage, and payment pathways.

• Real-world examples of reimbursement challenges and solutions.

12:55 PM – 1:10 PM: Implementing a Robust Quality Management System (QMS)

• Importance of a QMS in regulatory compliance.

• Key components of an effective QMS.

• How RQMIS assists in developing and maintaining a QMS that meets regulatory standards.

• Common pitfalls and best practices in QMS implementation.

1:10 PM – 1:20 PM: Q&A Session

• Open floor for questions from the audience.

• Interactive discussion on topics of interest or concern.

1:20 PM – 1:30 PM: Networking and Closing Remarks

• Recap of key points discussed.

• Networking opportunity for attendees to connect with RQMIS consultants.

Host or Publisher M2D2