DuVal & Associates, PA

??Join Us for Regulatory 101: Medical Devices 2025?? RAPS Twin Cities Chapter is hosting?Regulatory 101: Medical Devices 2025?on Monday, April 14, 2025, 8:00 am - 5:00 pm CST at Medtronic Mahle Auditorium. This full-day session brings together industry experts, regulatory professionals, Notified Body and FDA representatives to provide insights on medical device regulations. Featured Speakers: ??Lisa Pritchard, VP of Regulatory, Quality, Clinical and Engineering ??Aaron Hage, VP of Legal-Regulatory & Compliance ??Kathy Herzog, Senior Regulatory, Quality & Compliance Consultant Learn About: -Latest medical device regulation updates -Quality Management System requirements -Regulatory changes under the new administration -FDA submission strategies and pathways (510(k), De Novo, PMA) -Advertising and promotional compliance -Clinical evaluation requirements -EU and international regulatory changes -Post-market management and FDA interactions ??? Networking Opportunity Connect with industry veterans, including representatives from TüV SüD and FDA. Ask questions, share experiences, and build valuable relationships. ???Location:?Medtronic Mahle Auditorium, 8200 Coral Sea Street NE, Mounds View, MN 55112 ???Limited space available. Register before April 7th! Regulatory Affairs Professionals Society (RAPS) REGISTER: https://lnkd.in/ggjdQssP #MedicalDevices #RegulatoryAffairs #FDA #Compliance #RAPS #TwinCities #meddevice #networking

DuVal & Associates?is excited to announce that?Jessica Buell?has joined our firm as a Regulatory, Quality, and Compliance Consultant! Jessica Buell is a biomedical engineer and regulatory expert with over a decade of experience guiding medical device design and development from R&D through FDA clearance and global market entry. She has experience managing multidisciplinary technologies across neurological, vascular, dental, and general surgical fields. She specializes in Class I and II products, supporting 510(k) submissions, pre-submissions, FDA Breakthrough Device Designation, IDEs, De Novos, QMS creation and auditing, and grant submissions. Jessica brings over 10 years of exceptional experience in medical device development, with demonstrated success guiding products from early R&D stages through FDA clearance to market launch. Her impressive portfolio includes FDA-cleared devices such as EEG/MRI cloud-based decision support software, disposable cranial drills, stereotaxic instrumentation, and OTC acid reflux wearable technology. Most recently, Jessica spent nine years with Biotex (Houston, TX), where she led dozens of product development projects, managed multidisciplinary teams, and secured Breakthrough Device Designation for innovative technologies. Jessica's expertise in clinical studies, verification and validation methods, and regulatory submissions will be invaluable to our team. Her background in packaging and sterilization validation, electrical safety testing, software development, biocompatibility testing, and compliance with ISO and ASTM standards perfectly aligns with our quality-focused approach. Please help us welcome Jessica Buell to the team! ????

Bryan Feldhaus will be speaking at the annual MDMA FDA Forum!

You can find us at TODAY at MDMA'S FDA Forum in Palo Alto! Bryan Feldhaus, President of Legal-Regulatory and Compliance, will be speaking on De Novo best practices and will be accompanied by a panel of industry professionals. MDMA's FDA Forum promises to deliver key regulatory insights and preview trends that will impact your regulatory and business strategies. The forum is designed for medical device regulatory professionals and executive decision makers. What does the forum cover? -How to submit a quality submission -Premarket review innovation -Strategies to succeed during the review process -CDRH updates -Digital health-AI/ML -Biocompatibility -Cybersecurity DeNovo Best Practices: The De Novo pathway is a unique FDA regulatory mechanism for medical devices that do not have a legally marketed predicate device and are low to moderate risk. Best practices for navigating the De Novo process include: -Effective communication strategies with FDA reviewers -Providing thorough performance data and clinical evidence -Demonstrating a clear benefit-risk profile This promises to be a great event for the industry! Medical Device Manufacturers Association (MDMA)

?? DuVal & Associates Statement on FDA's Recent Reduction in Force ?? We were surprised to learn of FDA's decision over the President's Day weekend to eliminate probationary status personnel, particularly the impact on the Office of Product Evaluation and Quality (OPEQ). While we acknowledge the importance of government efficiency, OPEQ has been disproportionately affected. OPEQ's role is fundamental to FDA's mission. Funded primarily through industry user fees, OPEQ is crucial for ensuring timely access to safe, innovative medical devices. Staff reductions in this office will inevitably impact the introduction of new innovations to patients and their physicians. While we support efforts to address FDA's administrative inefficiencies, we believe these cost-cutting measures are misdirected. Reform should focus on reducing the administrative burdens on industry, including the failure to make regulatory decisions with fidelity to laws and regulations, ignoring least burdensome approaches, and arresting the avalanche of new rules and guidance documents. DuVal & Associates is actively engaging with Congress, industry associations, and key stakeholders to address these concerns. As regulatory lawyers and consultants with deep FDA expertise, we stand ready to help identify solutions that maintain OPEQ's essential role while improving overall agency efficiency. Read our full statement:?https://lnkd.in/dgCQAeR3 #FDA #MedicalDevice #Regulatory #Healthcare #Innovation #PublicHealth #MedTech

??As we reflect on 2024, we are filled with gratitude for the trust and partnership you've shown us throughout the year. Your continued support has been instrumental in our shared successes and growth.?? ? During this season, we want to take a moment to express our sincere appreciation for the relationships we've built and the opportunities we've had to serve you. Each project, collaboration, and interaction has reinforced the value of our professional community. ?? We're excited about the future and the chance to continue growing together. ??From all of us, we wish you and your loved ones a prosperous New Year filled with success, health, and happiness.?? Warmest regards, DuVal & Associates

??As we reflect on 2024, we are filled with gratitude for the trust and partnership you've shown us throughout the year. Your continued support has been instrumental in our shared successes and growth.?? ? During this season, we want to take a moment to express our sincere appreciation for the relationships we've built and the opportunities we've had to serve you. Each project, collaboration, and interaction has reinforced the value of our professional community. ?? We're excited about the future and the chance to continue growing together. ??From all of us, we wish you and your loved ones a prosperous New Year filled with success, health, and happiness.?? Warmest regards, DuVal & Associates

?? Join DuVal & Associates' Bryan Feldhaus and Aaron Hage at the Regulatory Affairs Professionals Society (RAPS) US Regulatory Essentials: Medical Devices Workshop! They'll share their wealth of regulatory knowledge alongside other industry professionals. Dive deep into FDA regulatory frameworks, QMSR requirements, and proven audit strategies. Master the essentials of design control principles, device classification, and submission processes. Plus, gain valuable insights on IVD/LDT specifics and critical labeling requirements. Perfect for regulatory professionals and industry newcomers looking to strengthen their compliance foundation and regulatory expertise. ?? December 18, 2024 ? 8:00 AM - 4:30 PM ET ?? Virtual Event ?? Starting at $680 for members REGISTER: https://lnkd.in/eDuP5P5f Ready to enhance your medical device regulatory knowledge? Register now to learn from seasoned industry professionals! #MedicalDevices #Regulatory #FDA #ProfessionalDevelopment #RAPS

??As we pause to reflect this Thanksgiving season, we're filled with gratitude for the incredible relationships that make our work meaningful. To our valued clients:?Thank you for your continued trust and partnership. Your innovation and dedication to advancing healthcare inspire us daily. We're privileged to be part of your journey. To our industry colleagues and friends:?Your collaboration, knowledge sharing, and support strengthen our entire professional community. We're grateful for the connections we've built and the insights we've shared. From our team to yours, we wish you a wonderful Thanksgiving celebration filled with warmth, joy, and meaningful moments with loved ones. May this season bring you peace, gratitude, and renewed energy for the year ahead. Happy Thanksgiving!??? #Thanksgiving?#Gratitude?#givethanks

?? Calling All Medical Device Regulatory Professionals! Dive deep into medical device regulations at our Regulatory Affairs Professionals Society (RAPS) ONE-DAY Online Workshop on December 18, 2024 (8:00 AM - 4:30 PM ET) ?? Workshop Highlights: -FDA regulatory framework overview -Audit & inspection strategies -Design control principles -Medical device classification -Clinical investigation insights -Labeling & advertising regulations ?? Learn from Industry Experts: *Mark DuVal, DuVal & Associates President *Etienne Nichols, Greenlight Guru *Sara Adams, Greenlight Guru * Sara Adams, Senior Medical Device Guru, Greenlight Guru * Chris Rush, Solutions Engineer, Greenlight Guru * Christie Hughes, Principal Consultant, Qserve Group * Vincent Cafiso, Director, Quality and Regulatory Services, CREO * Vernon Baker, Senior Medical Device Guru, Greenlight Guru ?? Registration: Members: $700 Non-Members: $825 REGISTER NOW: https://lnkd.in/gExNQSwa #MedicalDevices #RegulatoryAffairs #FDARegulations #ProfessionalDevelopment #RAPS