Tom Riniker, Consultant

triniker@gardner.law
‭+1 (651) 430-1912 office
‭+1 (612) 865-7862 mobile

Tom has been a leading provider of quality and regulatory consulting services to medical technology companies around the world for the last 25 years. He has led the design and implementation of quality management systems at numerous companies and guided remediation efforts to successfully resolve FDA 483s, Warning Letters, and Consent Decrees. For several years he has led St. Paul Consulting, a quality and regulatory consulting firm and prior to that held leadership roles within Danish medical device manufacturer, GN Otometrics. Tom is ISO 13485 and 9000 Certified.

22


CLIENT COUNTRIES VISITED

101


MOST DAYS SKIED IN A SEASON

Today’s regulatory environment is marked by increasing compliance demands and a higher frequency of changes to those requirements. Executives are challenged to find the expertise and capacity within their own organizations that are needed to effectively address and overcome these requirements. My clients appreciate the value that my 25 years of experience in the industry brings to their organization, as well as the expertise I’ve developed working with a variety of companies in the medtech space.
– Tom Riniker

Practice areas:
  • Remediation and resolution of FDA 483s, Warning Letters, and Consent Decrees
  • Supply Chain Planning and Management
  • New Product Development Program Management
  • Quality Management System Design and Implementation
  • QMS Software Package Selection and Implementation
  • ERP System Implementation
  • Quality Management System assessments
  • Investor Due Diligence

Tom has led St. Paul Consulting, a quality and regulatory consulting firm based in the Twin Cities. Most recently, Tom held leadership roles within Danish medical device manufacturer, GN Otometrics. He started as the Director of Global Regulatory Affairs/Quality Assurance and later became the General Manager of the company’s Canadian Operations.

  • Bachelor of Science, Business Administration, University of Wisconsin-La Crosse
  • Member of competitive alpine ski racing team
  • Coach of his four children in various sports
  • Former professional football player in Europe
  • ISO 13485:2016 Requirements for Medical Device Quality Management System
  • ISO 9000 Lead Auditor Certification