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Medical Device Directive Training

Regulators of medical devices, such as the FDA or Health Canada, expect manufacturers to do the necessary research into their own product and to provide proof of the device's efficacy. To this end, regulators issue directives in order to limit substandard requests for licensing. The training for providing a request that is likely to receive approval is generally provided through the use of "guidances," or guidance documents.

  1. Staff training

    • Regulators expect the manufacturers to train their own staff, but will provide consultation and advice as necessary. Study of previous decisions in the same manufacturing sector will be useful, as will paying strict attention to what the directive requests and what the guidance document amplifies. Staff should also train in good manufacturing processes and good laboratory practices.

    Training

    • The government bodies involved in regulation of medical devices make some training available. The FDA sponsors conferences, training events and webinars on its directives. Regulators in both the U.S. and Canada provide direct consultation on an as-needed basis. The training explains in-depth how to write a proposal, the need for compliance and the certificates and standards expected to be provided with the proposal.

    Additional Training Resources

    • In the U.S., organizations such as the Center for Professional Innovation and Education and the Center for Professional Advancement provide on-site training which will provide the basics required by the FDA, as well as more in-depth courses. In Canada, community colleges have courses for training staff in regulations and directives which are approved by Health Canada.

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