ISO 13485 is the Quality System Standard most commonly implemented by medical device manufacturers for meeting worldwide regulatory requirements. In fact, Canada requires that your Quality System be certified by a Health Canada recognized Third Party Registrar to CAN/CSA ISO 13485. Regulatory Insight has a full electronic library containing ISO 13485- and Part 820-compliant Quality Manuals, Quality Plans, Quality System Procedures, Quality System Forms, etc. that we customize to each client’s unique organization and operations. Fortunately, as ISO 13485:2003, CAN/CSA ISO 13485-03 and FDA’s Quality System Regulation overlap in many areas, we can cost-effectively design a compete Quality System for your company that is in full compliance with each of the ISO 13485 CAN/CSA ISO 13485 Standards and FDA’s Quality System Regulation (if needed), so that you have only one quality system that meets worldwide requirements. The Quality System we design for your company will specifically fit your company’s exclusive needs based on its size and its applicability to the ISO 13485 Standard (and FDA Regulations) – nothing more. If you plan to immediately, or even eventually, market your devices in both Europe and Canada, it is most beneficial to select a Health Canada recognized Third Party Registrar that is also a Notified Body for the EU. This will enable your Quality System to be assessed for both Canada and the EU at the same time. Regulatory Insight routinely works with Health Canada recognized Registrars who also are Notified Bodies. We can recommend the best fit for your company’s needs. If you already have a Quality System in place, but are not sure whether it is fully compliant with ISO 13485 and CAN/CSA ISO 13485, we can review it and identify any gaps before your Registrar/Notified Body identifies them during an ISO 13485 or CAN/CSA ISO assessment. We can then help you to proactively fill any gaps identified.