Q&R Canada Inc. delivers comprehensive medical device support and regulatory compliance services. We can assist you with many quality assurance, regulatory compliance and distribution management issues. We deliver practical advice and solid solutions to get the job done.
Q&R offers Medical Device consulting to assist you with bringing your medical device to market. The Medical Device Regulations outline the requirements for registration and sale of medical devices in Canada and encompass anyone who manufactures and/or imports medical devices sold in Canada.
Q&R offers a range of medical device consulting and regulatory solutions to help companies in the medical device sector operate within the relevant regulatory framework and comply with the requirements of the Medical Device Regulations fulfilling the expectations of the Health Products and Food Branch Inspectorate.
Our services in Medical Devices Consulting includes:
Classification and Submission
Complaints and Mandatory Problem Reporting
Navigating the medical device regulations can be complicated and costly. Let Q&R carefully evaluate your documentation and prepare a detailed gap analysis report showing what information you have and which data will be required for a successful submission.