Medical Devices

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
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

“Focal Point Research has consistently and professionally looked after regulatory and quality issues of our brand for years. Through a courteous and knowledgeable team, they have managed to navigate us through an ever changing regulatory landscape while maintaining our interests, and allowed us to correctly distribute and sell within Canada.”

“I have truly enjoyed working with you over the last 8 years! You and your team have been an amazing resource for me. I have always been impressed by the knowledge and professionalism of everyone at Focal Point, which is a true testament to your leadership.”

Connect With Us

The Focal Point Research team is ready to help with all of your scientific and regulatory needs.  Our team has the experience and expertise you need to see your product to market and we are eager to help you.