The decision of when to enter Design Controls is often unclear and arbitrary. When is the additional overhead “worth it?” Will FDA or other regulatory bodies push back on a late entry into Design Controls? What are some of the critical tasks we should accomplish in feasibility to optimize our work under Design Controls? This presentation explores the many facets of late feasibility and early Design Controls, including systems engineering best practices, regulatory involvement, and business risk. Priority Designs, in collaboration with CMD MedTech, will illustrate these key decision points through several case studies and provide the audience with a practical approach to “flipping the switch” between unregulated and regulated phases of a medical device development program.
ABOUT PRIORITY DESIGNS: Priority Designs brings over 30 years of product development experience to the medical device industry. Our full-service capabilities span the entire medical product development process, from initial human factors and usability, to design and development, to verification and validation. The medical design team includes biomedical engineering, human factors and usability researchers, designers, soft goods / wearable experts, and prototyping specialists. Our pragmatic approach to product development assures your product meets the needs of the users, development team, and ultimately, the FDA.
ABOUT CMD MEDTECH:
CMD MedTech provides medical device leadership expertise in the areas of Systems Engineering, Regulatory & Quality, Project Management, and Design and Development. CMD’s staff average over 15 years in medical device leadership roles, and have led dozens of programs launching innovative medical devices. CMD is a woman-owned small business and strives to improve the quality of life for patients and caregivers through partnering with our customers to develop safe and effective products.