Medical Device (MDEL) Consulting Services

Medical Device (MDEL) Consulting Services in Canada and United States

Focal Point Research provides exceptional professional services that will enable medical device companies from different parts of the world to gain unhindered entry into the United States and Canadian markets. We offer understandable technical advice to ensure U.S. FDA and Health Canada regulatory and quality system compliance is achieved for all classes of medical devices.

Focal Point Research offers the following
Medical Device Consulting Services:

MEDICAL DEVICES – Post-Market Surveillance (CANADA AND USA)

  • Establish and implement procedures to receive, analyze, submit and maintain Adverse Event (AE) records and/or Incident reports
  • Reporting of incidents to Health Canada and the FDA
  • Medical device market tracking, user information development and improvement post incident
  • Risk management via preventive action through design and manufacture of device
  • Assisting with implementation of corrective actions following an incident occurrence

Regulatory Affairs:

  • U.S. & Canadian Label Reviews
  • Class I, II or III medical device submissions to the U.S. FDA
  • Class I, II, III or IV medical device submissions to Health Canada
  • Representation at Health Canada pre-submission meetings
  • Representation at FDA meetings such as Pre-Investigational Device Exemption (Pre-IDE), Pre-PMA, 100-day PMA, Real-Time Supplementary
  • Applications for revisions to and maintenance of Medical Device Establishment Licenses (MDEL)

Quality Assurance:

  • Prepare for FDA QSR audits
  • Prepare for MDR/QMS ISO 13485: 2003 audits by Health Canada Recognized registrars
  • Periodic internal auditing, pre-regulatory audit inspections & QMS training for personnel
  • New or modified QMS certificate notification to Health Canada
  • Hosting Health Canada MDEL inspections
  • Writing and maintenance of SOPs


The Focal Point Research team of consultants is ready to help with your scientific & regulatory needs. Our friendly staff include scientists from various disciplines, regulatory and packaging experts and administrative support. We are eager to help you.

We provide our expertise to various businesses located throughout Canada and the United States, such as Toronto, Montreal, New York, Los Angeles, and many more.


  • 181 Lakeshore Road E. Mississauga, ON
  • 1 (905) 271 2709


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