Risk Based Design Control – The New Paradigm for Medical Device Design
José Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem-solving, and quality system methodologies. During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment. José led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge, Inc. at the University of Iowa’s business incubator park in Coralville, IA, creating a world-class medical device manufacturing operation, with JIT, kanban systems, visual workplace, and lean manufacturing practices.
José worked for 10 years at Cordis Corporation, now a Cardinal Health company, where he led the successful tooling, process development and qualification of Cordis’ first PTA (percutaneous transluminal angioplasty) catheter. His medical device experience includes surgical instruments, PTA & PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders, urology implants and devices for the treatment of incontinence, delivery systems for brachytherapy, orthopedic implants and instruments, and vascular surgery grafts and textiles. During his time at Cordis, José managed the Maintenance and Facilities Department, taking that operation to a level rated as “tops” by the UK Department of Health and Social Services (DHSS) during one of their intensive audits. Jose managed Manufacturing Engineering as part of the Guiding Catheter Core Team of managers, a team that took the Cordis Guiding Catheter business to lead the market, bringing it up from fourth place. By introducing world-class techniques, the Guiding Catheter design and manufacturing was completely re-engineered for robust design and tooling, under Jose’s leadership. He was also instrumental and played a leadership role in the complete re-engineering of the Tooling Control System, including design drafting, the tool shop, and technical support. Wherever he has worked, he has a track record of introducing world-class methodologies such as Kepner-Tregoe, Taguchi techniques, Theory of Constraints, Lean Manufacturing, Five S (Visual Workplace), process validation to Global Harmonization Task Force standards, and similar approaches.
Design Control is essentially a quality assurance program for the Research and Development department. The VP or Director of R&D owns the design control effort. Over the years many companies have included the design control requirements into their project plans and build the Design History File as part of the development process. Nothing has changed in these basics, but FDA’s and ISO’s expectations are now that risk management is built into the design and development process. Thus, the emergence of risk-based design control. This approach will be discussed in detail during this webinar.
- The 2019 approach to design control
- What do FDA and ISO say about it?
- How do you present it to management?
- What are the key steps in risk-based design control?
- How to implement risk-based design control in our company
Course Level - Intermediate
Who Should Attend
VP, Directors, Managers of R&D, Project Managers in R&D, VP, Directors, and Managers of QA, Internal Quality Auditors, QA Consultants to the medical device industry
Why Should You Attend
We must be prepared for quality audits. The MDSAP, ISO 13485:2016 certification, FDA PAI, and routine QSIT inspections. If these acronyms are familiar to you, then this is a webinar you should attend.
FDA Design Control has been around since 1996 when the FDA published the design control regulations as 21 CFR Part 820.30.
For many years establishing a design control SOP that included all the sections of Part 802.30 was all FDA expected. But things have changed, and FDA now expects a risk-based approach in addition to the basics.