About MDC

Since 1995, MDC, led by Trevor Lewis, has provided medical device commercialization, regulatory compliance, and quality management system (QMS) advice.

With a strong financial background, including experience as a London stockbroker, he aids funding bodies in market research and investment decisions. MDC's expertise spans from concept to market, facilitating profitable sales. Their focus on innovative devices and unique regulatory challenges sets them apart, serving universities, investors, law firms, and various medical companies.

Business Development

Find out how our strategic approach to business development will improve your return on investment…

Regulatory Affairs

Find out how our robust approach to regulatory affairs gets you fully compliant and keeps you on the path to success…

Quality Management Systems

Find out how our pragmatic approach to quality management systems ensures the outcome is beneficial to your business every day and to your compliance in international markets…

Welcome to The Medical Device Consultancy

In-vitro diagnostics, medical device, and related companies can benefit from MDC's business development, regulatory affairs, and quality management system (QMS) consulting services. MDC can help you meet the requirements of:

  • United States Food & Drug Administration (FDA).
  • European Union CE marking to MDR 2017/745 & MDR 2017/746, including ISO 13485 QMS compliance.
  • UK CA marking (UKCA).
  • Health Canada, including the Medical Device Single Audit Program (MDSAP).
  • Quality management system (ISO 9001 and ISO 13485) implementation, documentation, and certification including assistance with certification and surveillance audits.
  • UK Responsible Person (UKRP) services via trusted associates.

MDC offer specialist training, public or in-house, product management assistance, strategic market research, and partner selection. We have proven expertise with clinical evaluation, performance evaluation, validation work, and human factors engineering.