HELPING YOU FIND YOUR WAY TO QUALITY AND REGULATORY SUCCESS

 

WHAT WE OFFER

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QMS DEVELOPMENT & IMPROVEMENT

Value Beyond Compliance

EDUCATION & TRAINING

Know, Don't Guess

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REGULATORY INTERACTION SUPPORT

Preparation, Response, and Remediation

PERSON RESPONSIBLE FOR REGULATORY COMPLIANCE

Satisfying EU PRRC Requirements

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CLINICAL/PERFORMANCE EVALUATION REPORTS

CER / PER Authoring & Review

 
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SOFTWARE SOLUTION SERVICES

Selection, Design, & Validation

REGULATORY SUBMISSION SUPPORT

Authoring, Compilation, & Review

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QUALITY SYSTEM ASSESSMENT & AUDITING

Finding Gaps & Opportunities

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WHO WE ARE

 

MARK SWANSON

President

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.

STEVE GOMPERTZ

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.

RON LEANDER

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.

CONTACT US

833-QRX-PART (833-779-7278)

 

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