Medical Device Consulting Services for Canada

Emergo Group helps medical device and IVD manufacturers obtain regulatory approval from Health Canada. We can assist you with many Canadian MDR issues related to quality assurance, regulatory compliance and distribution management as shown below.

Medical Device License (MDL) and Medical Device Establishment Licenses (MDEL)

Emergo can assist in preparing the necessary paperwork to obtain a MDL or MDEL license from Health Canada.

ISO 13485 Quality Management System Consulting

Our consultants can implement ISO 13485:2003 or modify your QMS to meet Health Canada MDR regulations.

Health Canada MDR (Medical Device Regulations) Consulting

We can assist you with a wide variety of issues related to Canadian MDR regulatory compliance.

ISO 13485:2003 Training to Ensure Canadian MDR Compliance

Our on-site ISO 13485 training class is ideal for companies that need to train 3+ employees at one time.

Auditing for ISO 13485:2003 and Health Canada MDR Compliance

Emergo's auditors can ensure that you (or key suppliers) are maintaining compliance with ISO 13485 and the MDR.

Medical Device Distribution in Canada

Our team of specialists can find and qualify Canadian distributors that meet your specific needs.