Medical Device Consulting Services

Medical Device 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:

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

CONTACT

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.

GIVE US A CALL

  • 181 Lakeshore Road E. Mississauga, ON
  • mail@focalpointresearch.net
  • 1 (905) 271 2709
  • www.focalpointresearch.net

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