Act as your company Regulatory Affairs Consultant Agent

• We act as a liaison between your company and the various government agencies  responding to questions concerning medical devices and biosciences regulatory issues
• Will assist you and the regulatory agencies schedule inspections
• Help you resolve problems or delays and support your regulatory requirements
• We will ensure that all regulatory responsibilities and interests are handled professionally, confidentially and promptly. We can use our name for filing documents.
• MDBioregulatory.ca is an independent "third party" that will always look after your interests.
• The yearly maintenance fees are reasonable as your company Regulatory Affairs Consultant agent
• We provide a Regulatory Affairs Consulting service for the handling of Medical Devices Regulations and many other regulatoryissues in North America

 Premarket Approvals FDA 510K – USA

• Verify that the predicate device(s) you wish to use in your submission meet the criteria
• Provide the required direction during the premarket process
• Contact the FDA Office of Device Evaluation on your behalf  
• Assist in the preparation of the FDA  510(k) submission – Premarket Notification 510K
• Submit the FDA  510(k) application to the FDA 
• The Regulatory Affairs Consultant will work with the medical device company to resolve   additional questions or information as requested by FDA
• Act as the official agent for the company and handle all FDA discussions
• Conduct follow ups with FDA  related to the Premarket Notification Application  
• Collaborate the Safety and Efficacy summary and Risk Management Analysis  

 Medical Devices Regulations – Canada

• Prepare and submit Premarket Application for Class II, III and IV  
• Prepare Technical file compilation and product in accordance to regulations
• Verification of Essential Requirements for labels 
• Product classification and identification of applicable recognized standards
• Implementation and maintenance of ISO 13485 Medical Devices Quality System
• Canadian medical devices product and packaging review
• The Regulatory Affairs Consultant will work with the medical device company to prepare Risk Assessment ( ISO 14971)  
• Development of Vigilance Procedures for Recall, Adverse Event and Post-Market Surveillance
• Work with medical device companies to set up distributors, authorized representation for medical devices as required

Medical Devices Regulations – Europe (CE)

• Medical Device Directive and MEDEV guidance documents are used for Europe
• Our Regulatory Affairs Consultant will compile Technical File with evidence of compliance to the Medical Device Directive (or the IVD/AIMD Directives)
• Receive a CE Mark certificate from a Notified Body if medium or high risk device 
• Set up an Authorized Representative in the event you do not have one in Europe
• Register the medical devices with the Competent Authorities 
• When CE compliance are met CE Mark can be placed on your medical device