With over 175 years of combined Regulatory, Quality and Clinical experience, we have been helping companies all over the world in bringing medical devices and In-Vitro Diagnostics products to market.
At Methodize Inc., we match the consultant with the client, giving your company the specialized background knowledge and attention necessary to make your product a success.
We look forward to working with you.
Whether you are searching for the most effective way of pursuing a regulatory submission, starting up a clinical trial or need to meet a quality system regulation, Methodize is the one to call.
Once you have determined the classification of your device, you may need to start the process of a Premarket Notification submission.
ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices that consistently meet the applicable customer and regulatory requirements.
Methodize can help you decide which license is appropriate for your product and we will take you through the application process. Methodize can also modify your Quality Management System ISO 13485:2003 to comply with the Canadian requirements.
The CE Mark indicates that a manufacturer is compliant with the legal requirements of the EU “New Approach Directives” and European Regulations.
Clinical Trial Design and Protocol Development, Clinical Monitoring, Clinical Research Study Audits, and Post Market Investigations.
Methodize Inc. works with an Irish based company, Atlantico Systems, to provide you with an official EU Authorized Representative that will act as your liaison with the national Competent Authorities.
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