cover image: Guidance on Summary Reports and Issue-Related Analyses for Medical Devices

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Guidance on Summary Reports and Issue-Related Analyses for Medical Devices

12 Jan 2021

'This guidance document was prepared to help medical device manufacturers understand and comply with sections 25, 39 and 61.4 to 61.6 of the Medical Devices Regulations. Two new requirements in the Regulations were added to ensure the continued monitoring of benefits and risks after a product is authorized for sale in Canada'--Purpose of the guidance document, page 1.
health economy science and technology safety business information management human resources information medicine risk health care medical device clinical trial license health treatment adverse effect regulatory compliance business and finance
ISBN
9780660370385 0660370387
Pages
15
Published in
Ottawa, ON, CA, Canada

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