WHAT DO WE DO?
Stillwater MedTech Consulting solves your Quality, Regulatory and Operations problems.
We improve and remediate Quality Management Systems, provide guidance on regulatory strategies, improve operational efficiency, assess and ensure your compliance, and address complex clinical and reimbursement needs.
When designing practical, durable, and sustainable solutions for problems we are asked to solve, or that we discover during an audit, we consider your immediate and long-term needs.
OUR PROMISE
We dedicate ourselves to every assignment we take on. We never go half-way.
Our service teams are led by experienced business professionals who have worked in industry as leaders of the Quality, Regulatory, Operations, and Compliance functions.
We understand what it takes to run a business. We take great care to ensure that our assessments and proposed changes are practical and serve to better the business.
Whether you have a small assignment or a large a transformative project, Stillwater MedTech can help. For large assignments, we can imbed with your team, create a strategy designed for your special project, map out deliverables, and implement them alongside your staff.
OUR TEAM
Tom Riniker
Chief Executive Officer and Co-Founder
Tom is a Quality and Regulatory expert. He has been a leading provider of quality and regulatory consulting services to medical technology companies around the world for the last 25 years. During this time, Tom has led the design and implementation of quality management systems at numerous companies, achieving registration to ISO 9001 and ISO 13485 and compliance with numerous other related standards. Tom has also guided remediation efforts at multiple companies to successfully resolve FDA 483s, Warning Letters, and Consent Decrees.
Mark Gardner, M.B.A., J.D.
President and Co-Founder
Mark is a compliance and regulatory expert. He assists companies with: sales and marketing compliance under the AdvaMed and PhRMA codes, advertising and promotional review, federal and state sunshine reporting, answering regulatory questions, and making regulatory submissions.
He has worked in the medical technology industry for almost two decades. Nearly half of that time has been spent practicing regulatory law.* Mark worked in commercial roles at ev3 (Covidien-Medtronic), Celleration (Alliqua), and MedTox Laboratories (LabCorp).
Jim Murray, M.Sc.
Vice President, Operations
Jim is an operations expert. He assists companies with manufacturing operations; supply chain management, project management, and quality management systems.
Jim has filled leadership roles at St. Jude Medical, superDimension, and 7 other medtech startups. Jim has led major product development programs, formulated operational and quality system strategies, managed manufacturing operations for devices and drugs, managed supply chains and contract manufacturing, developed and implemented quality management systems, and contributed to numerous IDE, PMA, IND, and NDA submissions.
Amy Fowler, J.D., R.A.C
Consultant
Amy is a submissions expert. Amy has spent the last 26 years getting medical devices and pharmaceuticals to market. She counsels clients on regulatory strategies and prepares Pre-Submission, 510(k), De Novo, IDE, IND, DMF, and NDA submissions. Amy also is an expert on U.S. and E.U. UDI issues. She can help you prepare and meet with FDA, whether it is a Pre-Submission, appeal or other critical issue. Amy previously worked at 3M, Dentsply, Ecolab, and RCRI.
Dave Teicher, M.Sc., J.D.
Consultant
Dave is a regulatory expert. He has a thirty-five year career specializing in FDA regulatory affairs. He focuses on regulatory strategies, preparing domestic submissions, and creating and implementing quality management systems for compliance with FDA’s QSR and international regulations and standards.
Ed Erickson, Ph.D.
Consultant
Dr. Erickson is a pharmaceutical expert. Ed provides strategic advice on the viability of new pharmaceuticals, and how to bring them to the U.S. market. He offers decades of R&D, business and regulatory experience. After receiving his Ph.D. in Organic Chemistry with an emphasis on Rational Drug Design, Ed began his healthcare career as a medicinal chemist with Riker Laboratories.
*Although some of our staff have a license to practice law, Stillwater MedTech Consulting does not provide legal services, legal opinions or legal advice.
Thoughtful and rapid assessment, efficient and effective change implementation, and lasting knowledge transfer are hallmarks of Stillwater MedTech Consulting.