CFO at Concentric Analgestics, Inc.
We hired Michael as a consultant to architect a comprehensive regulatory
strategy for a new salivary diagnostic product. Michael did an outstanding job in all aspects of the assignment. In addition to the superb regulatory guidance he provided, I was pleased by how
quickly and well he proactively partnered with our clinical, scientific and marketing teams to support clinical study design, prototype development, and marketing strategy. Michael brings a wealth of
regulatory and product development experience to the table and his contribution to the corporate strategy was well-reasoned and cost-effective. I recommend him without reservation and with great
President at Kestrel BioSciences
We contracted with Michael Wienholt to shepherd us through the ISO13485 Certification process for our small diagnostics
company. He expertly assisted our team and seamlessly integrated with our quality system, bringing that system fully up to necessary standards. Michael was professional, exceeded our
expectations regarding the timeline. We successfully achieved our certifcation thanks to his attention to detail and wealth of knowledge.
and CEO at Medical Devices and Diagnostics
Michael is one of the most thorough Regulatory Affairs / Quality
Assurance experts that I've ever worked with over the years. His ability to prioritize issues, develop a regulatory strategy, and successfully implement a tactical plan are exemplary.
Michael was responsibile for getting our company ready for a FDA visit, and single handily drove the company towards a successful audit/inspection. I would welcome the opportunity to work
with Michael again.
& Scientific Affairs Executive
Michael is one of the most knowledgeable regulatory professionals I have met. His
experience with different products is sufficiently broad that he is able to merge this experience with his knowledge of the current regulatory environment to craft effective and timely regulatory
strategies. He functions with a great deal of professional and personal integrity. He is passionate about his duties and his candor provides essential transparency to executive leadership
and cross-functional teams. I found Michael to be a problem-solver and a productive teammate and I would welcome the opportunity to work with him again.
and CEO at KFx Corporation
In my opinion, it is hard to saying anything better about Michael than after he
worked for me for a number of years, I hired him again. And would do so again! Super work.
President at IVD Research Inc
Michael was critical to my companies FDA 510(k)
applications. He came highly recommended from a mutual business friend. Very results driven. Also knows a number of the FDA reviewers personally.
December 9, 2010
the project lead for a software project, which is the first project in the company following the design control process. We were very fortunate to have Michael directing us on QA and Regulatory
issues. Michael has a deep knowledge about the FDA and ISO regulatory and quality requirements. He was instrumental setting up the quality system process for the entire company. In
addition, Michael is a top notch leader. He always resolved the conflicts and issues escalated to him effectively and fairly, in big part based on his subject expertise, on-the-mark assessments
and great communication skills. I admire Michael for his talents, commitments and communication skills. With his proven leadership skills, FDA/ISO quality system and submission expertise,
I am sure Michael would bring great values to any organization in the medical device or other regulated fields. I recommend him without any reservation.
Director of Engineering
July 25, 2010
Michael is one of the few RA people that I have worked with in 20 plus years in Medical
Diagnostics that understands and practices an appropriate mix of QA/RA oversight, combined with a practical understanding of the product development process, without stifling creativity and
innovation. He quickly earns the respect of all his colleagues in the engineering and scientific disciplines. His expert quidance and recommendations are highly appropriate, and are
always accompanied with sound reasoning and logic. He is "big picture" strategic, and detail orientated, as appropriate.