Medical Device Compliance
Medical Device Compliance & Quality
Solutions
- Medical devices cover health and medical instruments such as pacemakers, hip implants, thermometers, syringes, artificial heart valves, and medical diagnostic instruments.
- Health Canada regulates the manufacturing, distribution, importation, and sale of medical devices in Canada by enforcing Medical Device Regulations.
- Medical devices in Canada are classified into four classes based on their associated risks (Class I to Class IV). Class I devices (such as wheelchairs, and bandages) present the lowest risk while Class IV devices (such as a pacemaker) present the highest potential risk.
- Class I medical devices only require an MDEL (Medical Device Establishment License) while class II, III, and IV medical devices require both MDL (Medical Device License) and MDEL.
Services Provided by CanSat Consulting
- Medical device license (MDL)
- Medical device establishment license (MDEL)
- MDEL annual renewal
- Designing standard operating procedures
- Training programs for entry, mid-level, and senior management
- Site and QMS audit services (a must before regulatory inspections)
- Preparing and reviewing compliant labels