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We at RS Consultant Services can help you in providing expertise to deal with the regulations.

Quality System Requirements for Medical Devices:

Starting January 01, 2004 all manufacturers of the medical devices are required to have ISO certification. Manufacturers of class II, III and IV devices must be certified to ISO 13485:2003 standards. The registrars auditing the companies for these standards must be recognized to CMDCAS (Canadian Medical Devices Conformity Assessment System).

All new submission must include an ISO 13485:2003 CMDCAS certificate with the application.

All previously licensed device must also meet this requirements.

We provide assistance to companies who need to become certified in order to comply with these standards.

RS Consultant Services provides ongoing management of all regulatory functions for many companies and can provide the following services for your company:

Medical Devices:

Regulatory Consulting Services

Canada:

•   Submission for class II, III and IV devices license applications and follow-up with the Medical Devices Bureau to the license approval stage as needed
•   Submission for clinical investigation of the devices:
•   Reviewing of information,
•   Providing feedback re: additional information that may be required,
•   Preparing submission dossier,
•   Filing with Medical Devices Bureau and responding to the follow-up questions, completing the authorization process of investigational testing
•   Establishment license preparation and approval
•   SOP preparations
•   Preparing procedures according to HPFBI guidelines
•   Preparing Importer/Distributors to meet requirements of HPFBI inspections
•   Submission for special access devices and custom-made devices

USA:

•   510 k submissions
•   Registration and Device Listing

ISO 13485:2003:CMDCAS Quality Management System

•   Planning for quality management system, help in preparing documentation, working with staff to implement the system, providing training, help with registration process and continuous support and, organizing internal and registration audits

Pharmaceutical:

•   Establishment Licence Applications
•   GMP Compliance
•   DIN Applications

Natural Health Products:

•   NPN application preparations
•   Site Licenses application preparation

To enquire about any of our services please contact us: Contact Information
Or Call: (905) 918-0272 / Cell: (416) 562-2584