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, MDSAP Auditor and EU MDR Auditor.
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.
Senior Quality and Regulatory Consultant
Angela is an independent consultant who has worked in the medical device industry for over 15 years. She has extensive experience in the medical device industry.
She is an ASQC Certified Quality Auditor, a certified EU MDR Auditor, and a certified ISO 13485:2016 Lead Auditor. Angela is experienced with clinical and hospital laboratory quality systems, including accreditation requirements, clinic trial management, and GCP (good clinical practice). Her expertise also includes 21CFR 820 requirements, including medical device software, design history file documentation and verification/validation procedures. Her broad background includes the EU General Data Protection Regulation (GDPR) and the Medical Device Single Audit Program (MDSAP). Angela is an experienced trainer and provides excellent customer service.
Senior Regulatory Consultant
Sheila Ramerman is an independent consultant who has 30 years’ experience in the medical device industry, including consulting to medical device companies since 2003. With her initial education and work experience as a hospital lab tech in addition to industry R&D work, Sheila is especially familiar with IVDs and other point of care testing devices. She has extensive expertise with Software as a Medical Device (SaMD), body-worn sensors, and medical apps. She primarily works with entrepreneurs, start-ups and small companies, whether they are brick-and-mortar or virtual entities. Products Sheila has worked with range from complex, software controlled devices for detection, diagnosis or therapy to general hospital, neurology, physical medicine, and surgical devices. In the past, Sheila has been a webcast instructor for BioPractice.com and was active in the early days of OBA’s WorkForce Training program. In the US, she has successfully submitted numerous pre- IDE/pre-submissions, over 40 Traditional and Special 510(k) submissions, a radiology image analysis software PMA, and multiple de novo applications. Worldwide, Sheila has experience with premarket and postmarket requirements in Canada, EU, and Asia-Pacific regions.
Her LinkedIn profile (https://www.linkedin.com/in/sramerman/ ) describes her career in more detail.
Sheila holds an AA degree in Clinical Laboratory Technology from Shoreline Community College in Seattle, WA and a BA in Health Services Administration from Saint Mary’s College in Moraga, CA. She has been Regulatory Affairs Certified (RAC) by the Regulatory Affairs Professional Society since 1998, and RAC-Devices certified since 2019.
Michael P. Nilo, MS
Principal 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.
Marianne D. Jacklyn
Senior Quality and Regulatory Consultant
Marianne D. Jacklyn is a Regulatory Affairs professional with a pragmatic, collaborative approach to achieving FDA approvals of medical devices. With over 20 years of experience, she has authored or directed PreSubmission, IDE, PMA, HDE, and 510(k) submissions. She has worked with Class I, II and III devices, including active and passive implants, combination products and software, with applications in vascular intervention, cardiac rhythm management, cardiac surgery, orthopedic surgery and general surgery. In addition to submissions, Marianne has expertise in regulatory compliance for registration and listing, UDI, change management, labeling, advertising and promotion. She has held leadership positions in companies ranging from early stage startups through IPO and acquisition to large publicly held and private corporations with both domestic and international operations. This breadth of experience enables Marianne to develop and execute regulatory strategies to serve business objectives. For more details see her LinkedIn profile.
Marianne has a B.Sc. in Mathematics, Chemistry and Physics from McGill University.
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.