Health Canada CMDR Medical Device Regulation & CMDCAS Consulting
Emergo Group offers medical device & IVD companies a wide array of quality assurance and regulatory affairs services through its Canadian offices in Vancouver and Toronto. Health Canada related medical device consulting services are shown below, or you can see a complete listing of all Emergo Group services by clicking here.
> Quality Assurance Consulting Services
ISO 13485:2003 quality system implementation or upgrade
We have implemented and upgraded ISO 13485:2003 quality systems for hundreds of medical device companies.
ISO 13485 quality assurance (QA) outsourcing
We offer QA outsourcing on a monthly, quarterly or “As Needed” schedule and can assist with audits, document control and more.
ISO 13485 & GMP quality system and supplier audits
Our team of Certified Lead Assessors can audit your ISO 13485 and GMP quality system, or conduct audits of your suppliers/subcontractors.
ISO 14971 risk management consulting
Let us help you adopt the ISO 14971:2007 risk management standard and integrate it with your existing ISO 13485 system.
> Regulatory Affairs Consulting Services
Canadian regulatory compliance consulting
With offices in Canada and US, we can handle all of your Health Canada CMDR and CMDCAS regulatory issues.
Technical File compilation
Hundreds of medical device companies have enlisted our support to compile Technical Files for a wide range of medical devices and IVDs.
Canadian Medical Device Establishment License and Medical Device Licence
Health Canada requires most companies to file an MDEL and MDL before they can sell in Canada. We can assist with the preparation and filing of these licenses.
