Medical Devices
The following procedures are written according to Health Canada “Medical Devices Guidance Documents”. Needless to say, the interested parties are advised to visit the section on “Drug GMP SOPs & Policies” to complete other GMP procedures requirements.
Procedures
| Document Description | Price (USD) | Click To Purchase |
|---|---|---|
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Document Title: Contents of The Mandatory Problem Report Document Purpose: The purpose of this procedure is to provide guidance on the preliminary and final report contents, concerning mandatory problem reporting. |
63.00 $ |
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Document Title: Medical Devices Distribution Record Document Purpose: To define the requirements to maintain a distribution record of each device the company distributes
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52.50 $ |
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Document Title: Medical Devices Recall Follow Up Document Purpose: The purpose of this procedure is to specify the steps required for evaluating the recall’s effectiveness and the remedial actions.
|
42.00 $ |
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Document Title: Medical Devices Recall Initiation & the Recall Strategy Document Purpose: This document is intended to provide instruction on identifying the need to initiate a recall and to provide guidance on how to establish/ develop the MDrecall strategy.
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105.00 $ |
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Document Title: Medical Devices Recall Reports Document Purpose: This document is intended to provide information on the recall reporting activity and.to provide instruction on the procedure of submitting the Medical Devices recall report to health Canada.
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73.50 $ |
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Document Title: Medical Devices Recall: Customers Notification & Correction Document Purpose: The objective of this document is to describe the steps to be followed to conduct an effective customers notification and correction.
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63.00 $ |
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Document Title: Medical Devices Recall: Review and Closing Document Purpose: The purpose of this procedure is to provide guidance on how to evaluate the recall’s effectiveness and how to determine if the recall is ready to be closed.
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52.50 $ |
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Document Title: Medical Devices: Documents Distribution and Control Document Purpose: The purpose of this document is to provide guidance on how the company should manage documents’ distribution and control among company employees. This is to assure that all employees are updated and well knowledgeable about the company procedures and policies changes.
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63.00 $ |
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Document Title: Receipt and Recognition of Medical Device Problem Document Purpose: This document is to provide instructions on receipt and recognition of Medical Device Problem for conducting problem report investigations and to describes the type of information that should be gathered on a problem report.
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84.00 $ |
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Document Title: Responsibilities of Manufacturers, Importers & Distributors Document Purpose: The objective of this document is to outlines the roles and responsibilities of Medical devices manufacturers, importers and distributors. Also, to provide instructions on establishing an effective and timely system for conducting problem report investigations that complies with Health Canada requirements.
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73.50 $ |
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Document Title: Risk Analysis, Evaluation and Control Document Purpose: This document is to describes how the company should manage the root cause investigation, risk analysis and risk evaluation in order to comply with the Regulations.
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94.50 $ |
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Document Title: The Mandatory Problem Report Requirements PURPOSE: Document Purpose: The purpose of this procedure is to provide guideline on mandatory problem reporting requirements and to specify the reportability criteria and the time frame for reporting an incident to Health Canada.
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73.50 $ |
