CMDCAS

  • Canadian Medical Device Directive

    Manufacturers of Class II Medical Devices must demonstrate conformity to an ISO 13485:2003 quality management system (with the exclusion of design and development)
    Manufacturers of Class III and IV devices must demonstrate conformity to a full ISO 13485:2003 quality management system including design and development
    Class 11, 111 and 1V systems must be certified by a nominated CMDCAS Registrar
    The ISO13485:2003 quality system must be certified by a Canadian Medical Devices Conformity Assessment Scheme (CMDCAS) Recognized Registrar

    Lawrence-Hall Consultants working closely with you, develop and implement your quality system and technical files.  Our highly experienced and qualified consultants take the burden and stress from you and ensure your systems and documentation will meet the regulatory requirements.   Should you wish, your consultant will be present during the Notified Body assessment
    Our consultants begin the certification process by conducting a Gap Analysis of your systems and documentation. The analysis report identifies the areas that are not in compliance with the CMDCAS requirements and includes an action plan and timescale for full system implementation

New Service

As new quality management systems are created to keep up with the
climate of change within the business world, Lawrence Hall are ahead of the game, updating our knowledge base of systems in order to provide our customers with new services.