HELPING YOU FIND YOUR WAY TO QUALITY AND REGULATORY SUCCESS
WHAT WE OFFER
QMS DEVELOPMENT & IMPROVEMENT
Value Beyond Compliance
EDUCATION & TRAINING
Know, Don't Guess
REGULATORY INTERACTION SUPPORT
Preparation, Response, and Remediation
PERSON RESPONSIBLE FOR REGULATORY COMPLIANCE
Satisfying EU PRRC Requirements
CLINICAL/PERFORMANCE EVALUATION REPORTS
CER / PER Authoring & Review
SOFTWARE SOLUTION SERVICES
Selection, Design, & Validation
REGULATORY SUBMISSION SUPPORT
Authoring, Compilation, & Review
QUALITY SYSTEM ASSESSMENT & AUDITING
Finding Gaps & Opportunities
WHO WE ARE
Mark has been a leader in Quality and Regulatory for over 25 years. His career includes roles in quality engineering, design assurance, audit, and quality management for companies including St. Jude Medical and Medtronic, and has provided guidance to numerous medical device and pharmaceutical manufacturers of all sizes,. Mark is also an Adjunct Instructor in St. Cloud State University’s M.S. in Medical Technology Quality program. He holds a B.S. in Electrical Engineering from the Univ. of MN, an MBA from Argosy University, and certifications in quality management, auditing,, and quality engineering.. Mark was also a member of the working groups that developed the most recent updates to ISO 13485, ISO 9001, and ISO 14971, and serves on several AAMI committees.
Chief Operating Officer
Steve has been a leader in Quality Systems management for over 25 years. His career includes roles in quality systems development and implementation, project management, engineering automation, configuration management, audit, and software development for companies including Pelican Biothermal, St. Jude Medical, Boston Scientific, Medtronic, and Vital Images,. Steve also helped develop and is an Adjunct Instructor in St. Cloud State University’s M.S. in Medical Technology Quality program. He holds a B.S. in Mechanical Engineering from Lehigh University, and certifications in quality management, auditing, project management, and configuration management.
Chief Financial Officer
Ron is passionate about helping companies grow and brings a lifetime of experience and unique breadth of expertise. Prior to starting his practice, he worked for 3M, Medtronic, Jostens Access Cash International. Ron earned a B.S. in Accounting from Minnesota State University, and is a CPA.
Business Development Director
Tom’s entire career in business development has been guided by a strong focus on client needs and client success. This has led to sales growth and achievement at multiple companies including Compuware and SWAT Solutions. His background encompasses work in multiple industries including graphic arts and software development. For the last 20 years he has been helping clients in medical device companies such as Boston Scientific, Medtronic, and St Jude Medical to achieve success. Tom attended the University of Minnesota and has a Degree in Advertising Illustration from the New England School of Photography.