Rob Packard, a Quality System & Regulatory expert of Medical Device Academy, was gracious enough to allow us to post these articles he wrote recently on Canadian Medical Device Regulations. Thx Rob!
The first article is a hypothetical case study that explains the process of obtaining a Health Canada Medical Device License.
The second and third articles are a 2 Part Series on the 11 Steps to Obtaining CMDCAS Certification.
- Part 1 focuses on the process of verifying the classification, selecting a registrar and obtaining a quote for CMDCAS certification.
- Part 2 focuses on the process of updating the quality system (Licensing, Mandatory Problem Reporting, & Recall Procedures), finding a distributor, training your staff that touches parts of the quality system that are impacted by the CMDR, conducting internal auditing to applicable sections of the CMDR, going thru the CMDCAS certification audit, and lastly if applicable your Submission of your License Application.
If your company needs help or support on Canadian Medical Device Regulations we have several staff members that can assist with that. Please contact or call us at 503-244-6151.
Case Study for Health Canada Device License & 11 Steps to Obtain CMDCAS Certification