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 or STED to obtain a MDL 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.
Health Canada Regulatory Compliance for EMR system manufacturers
Manufacture Electronic Medical Record (EMR) systems? Let us assist you in complying with Health Canada's new upcoming medical device requirements.
Medical Device Distribution in Canada
Our team of specialists can find and qualify Canadian distributors that meet your specific needs.
Click on the image to download this PDF of the medical device approval process in Canada
