What people are saying...

Frank Bellizzi

CFO at Concentric Analgestics, Inc.

January 2015

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 enthusiasm.

Jeff Bauer

President at Kestrel BioSciences

January 2015

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. 

Timothy Still
President and CEO at Medical Devices and Diagnostics

September 2014

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.

Jeff Dahlen
Medical & Scientific Affairs Executive

September 2014

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.

Tate Scott
President and CEO at KFx Corporation

September 2014

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.

Dave Lambillotte
President at IVD Research Inc

May 2011

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.  

Jin Ruan

Software Development Manager

December 9, 2010

I was 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. 

Ron Boyd

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.

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