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“Thank you for jumping up to the plate on this project so quickly and still providing such quality work. We are excited to continue working together.”
–Mitchell Barneck, Chief Technology Officer, Veritas Medical LLC.
“The Vision 28 team has an extraordinary ability to balance work loads and priorities for both the organization and themselves. Their depth of knowledge and wisdom in the field of RA/QA enabled us working together to be strategic about how we deployed new projects while we completed others. The team’s ability to command attention during meetings was well respected while she was seen by all as a business partner. I enjoyed working with Vision 28 very much as I knew they always gave me sound advice and leadership.”
–Darko Spoljaric, Vice President Global Marketing, NDS Surgical Imaging
Linda’s warm and positive demeanor make working with her a real pleasure. Match that with her precise, focused and unparalleled regulatory expertise and you’ve got the recipe for a team player that gets the job done. I always look forward to working with her as I know if Linda’s in position as our regulatory advisor, we are on a successful product development path!
–Brenda Edin, Partner at Due North Innovation
Thanks to Tom for preparing me for an ISO 13485 audit with our Notified Body and for doing a superb job of crafting a Quality System that satisfies the ISO specification but is not overly cumbersome for us to utilize. Job well done!
–Eric Bean, Ph.D., VIce President of Research and Development, DiabetOmics, Inc.
I had the pleasure to work with Rich at Abbott Laboratories. My first extensive interaction with Rich was during a significant problem we experienced with product in the field. We knew what was happening and why it was happening, product was being damaged by its conveyance method post manufacture, it did not affect the entire product in the field, but we had not determined how to predict which lots would exhibit the problem. In stepped Rich; he and his engineering staff, with a very logical, scientific and data driven analysis developed a modeling method which accurately predicted field experience with the product. The method stood up to extensive internal review and that of involved regulatory and clinical reviewers. Without a doubt, Rich was instrumental in saving a billion dollar business and in assuring the safe ongoing supply of a critical product for our customers. Rich went on to additional higher organizational level work and accomplishments with Abbott. There are engineering mangers and there are managers who are engineers, Rich is a solid and talented general manager who is also a terrific engineer – a difficult combination to beat.
–Nick Dayton, PhD, Senior Director Quality, Baxter International Inc.
I worked with Rich two different times while we were at Abbott. For the first couple years we were in separate groups, in separate states, working on a complex drug compounding device. Later Rich was promoted to plant QA manager where I was a manufacturing manager. Each time he was very analytical and detail-oriented, insisting on understanding and truly correcting the root cause of issues. Sometimes that lead to some long philosophical/technical discussions that I thoroughly enjoyed!
Kevin Meyer, Co-founder of Gemba Academy, former medical device company president, investor, speaker, author.