President & CEO
Rich Wynkoop is a seasoned executive who takes a pragmatic approach to quality management, regulatory affairs, and compliance to achieve cost effective and successful outcomes. His experience spans world-class enterprises and multi-national organizations in medical device industries as a hands-on Quality Engineer, R&D Manager, QA Plant Manager, Director QA&RA, and Vice President QA&RA. This range of experience enables him to quickly target pragmatic solutions to difficult problems. Rich has also spent significant time preparing for and hosting regulatory audits and remediating difficult audit observations. He has designed and implemented Design Control, Software Validation, CAPA and other quality system elements that have stood up to robust examination by both Notified Bodies and FDA inspectors.
Rich has a BS in Electronics Engineering from Oregon State University, an MBA from Phoenix University, and was registered as a Professional Engineer in the state of Illinois. Rich was also a certified Zener Miller team facilitator and a certified DDI Leadership facilitator. Certified ISO 13485:2016 Lead Auditor.
Sue Hart has been a director, program manager, and project manager in R&D for over 2 decades. She has also been a manager in the QA Department. Her experience includes cross-functional leadership & coordination among R&D, QA/RA, marketing, human factors & usability testing, manufacturing, user documentation, and technical support teams to develop world-class multi-national new products from initiation through release deployment, mainly for medical devices. She has a demonstrated history of project planning and delivery to schedule and budget expectations. Sue has a history of excellent QMS Design Controls results, especially Design History File results. FDA inspection results in this area have consistently been excellent. Products have consistently improved in terms of quality with her leadership. Recent R&D projects have been full SDLC cloud-based using Agile methodologies. Her project management experience also includes projects with EE and ME aspects.
Sue has a BS in Computer Science with a concentration in engineering and options in both systems and applications from Montana State University. She has an MS in Computer Science from California State University, and an MBA from Boston University. She is a certified Project Management Professional (PMP). She has a certificate in AAMI Quality System Requirements and Industry Practice.
Senior Consultant (Emeritus)
Linda J. Bovard, has provided services to medical device companies for over 30 years, more than 20 years as a consultant. She worked across the product lifecycle, but particularly enjoyed strategic planning and teaching those new to the industry. In her retirement, Linda helps out Vision28 from time to time as an advisor.
Her provides more specifics on her career.
Linda has a BA in Biology from Swarthmore College. She maintains is certified as a Regulatory Affairs professional (RAC) through the Regulatory Affairs Professional Society (RAPS). Linda has attended internal auditing, clinical auditing, and train-the-trainer courses as well as numerous seminars and conferences. She is committed to continuing education to keep up-to-date in these constantly changing fields.
Quality, Efficiency and Regulatory Affairs Consultant
Tom Renner is an independent consultant who has worked in the medical device industry for 20 years. He has hands-on familiarity with most functions and departments of a successful medical device startup, and has built and managed processes and teams for technical writing, software and hardware development, quality assurance, and regulatory affairs. He has extensive experience with medical device software, quality system development (ISO 13485, ISO 14971), FDA 510(k) clearance, and CE mark under the Medical Device Directive (93/42/EEC). He’s an effective public speaker, teacher, copy editor, and troubleshooter with a strong foundation in physics, chemistry, biology, mathematics, and written language.
Tom has a BS in Engineering & Applied Science from Caltech. He maintains a RABQSA Lead Auditor certificate for ISO 9001:2008 and ISO 1348:2003.
Michael P. Nilo, MS
Senior Regulatory Consultant
In his six years with FDA, Michael has reviewed well over 100 medical device pre-market submissions (IDE, 510(k), PMA, DeNovo and HDE) to determine if devices were safe and effective. A few of the pre-market submissions Michael has reviewed include drug eluting stents, atherectomy systems, percutaneous transluminal coronary angioplasty balloons, guide catheters, embolectomy, dental implants, abutments, bone-grafting materials, bone plates, and trans-mandibular joint implants. He has an excellent grasp of what FDA reviewers are looking for in all submissions. In private industry, he has developed successful regulatory strategies and authored/submitted pre-IDE, 510(k), HDE, IDE and original PMA submissions to FDA for cardiovascular device systems and combination products (e.g., drug eluting stents and absorbable scaffolds). See his LinkedIn profile for more details (www.linkedin.com/in/michaelnilo). Michael brings a wealth of knowledge, experience and regulatory networking to Vision28.
Michael has a Master of Science in Biomedical Engineering from the University of Alabama at Birmingham, and graduated Summa cum Laude from the University of Pittsburgh, with a Bachelor of Science in Bioengineering and Chemistry. He has completed ISO 13485, AAMI Quality Systems and Six-Sigma (Green Belt) training.