Unparalleled in Our Approach
Only Stillwater MedTech Consulting offers the integration of Quality, Regulatory, Operations, Commercialization, Clinical, and Reimbursement consulting services. This unique approach to client service for medical technology companies allows us to help clients through the challenges associated with each stage of the development lifecycle. We incorporate a total business improvement philosophy and deliver personalized assistance with tangible value.
QUALITY
REGULATORY
OPERATIONS
COMMERCIALIZATION
CLINICAL
REIMBURSEMENT
OTHER
Stillwater MedTech brings a seasoned, practical approach to all our Quality Compliance and Regulatory program needs. Their experience in the medical technology industry provides unique insights to help support our business needs. With services truly client-focus and practical, I would highly recommend Stillwater Medtech to any medical device company
Tim Kappers, MBA, RAC, Vice President, Quality & Regulatory Affairs, Cardiovascular Systems, Inc.As a start-up medical device company, we needed to act quickly and partner with a firm that understood our objectives and supported our aggressive timeline. As the Director of Quality, I needed dedicated assistance with establishing a full Quality Management System that would enable us to move through the rigorous ISO 13485:2016 certification cycle.
Stillwater Medtech Consulting assigned Jim Murray, who worked directly with our team and embedded himself within our culture, making it extremely seamless to communicate and collaborate on the tasks at hand. Jim became a valuable team member, who not only advised us, but physically did the work. A true combination that many consulting firms lack.
With Jim’s guidance and hard work ethic, we were able to fill in gaps and successfully complete our stage 1 audit on time. We are excited to share the same success, as we move through the certification process.
Mike Bielski, MBA, Director of Quality, HistoSonics, Inc.