Profile

MR John Minier, RAC

Minier Medical Device Consulting

Contact Details

Minier Medical Device Consulting

Social Links

Bio

I have Quality Assurance, Regulatory, Product Development,Project Management, Clinical Research, and Global Sales & Marketing experience in the medical device industry. My clients are mostly small businesses and start up companies.

My specialties include medical device PMA and 510(k) submissions, CE marking and technical file creation in compliance with the new Medical Device Regulations (MDR), and Unique Device Identification (UDI) compliance.

I also have significant Quality Assurance experience including Quality Management Systems, vendor evaluation/control, risk management, CAPA's, and postmarket surveillance.

I live in the beautiful Hudson Valley Region of New York state. In my free time I enjoy hiking, skiing, and restoring and racing my 2004 Miata Mazdaspeed.

Position Title

  • Director
  • Principal

Education

Florida International University
Ft. Lauderdale, Florida, United States
Master of Business Administration

Year Entered Profession

  • I started in Marketing/Sales in 1984, Project Management in 1992, R&D in 1997, QA in 2005, and RA/CA in 2008.

Current Organization Type

  • Industry

Job History

JMC Medical, LLC
Senior Regulatory Compliance Consultant
August 2016 - present

Minier Medical Device Consulting
Principal / Consultant
August 2016 - present

Product Interests

  • Biomaterials
  • Combination Products
  • IVDs
  • Medical Devices