SOPs for Medical Devices

The Medical Device Industry requires specific Quality Management tools and controls. Our Quality Management Manual and SOP templates are built mainly on ISO 13485 and 21 CFR 820 requirements. Our document portfolio consists of a wide range of documents, templates and forms for the Design Controls and the Life Cycle Management of Medical Devices.

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  1. Medical Device Design Verification SOP

    Medical Device Design Verification SOP

     This Standard Operating Procedure (SOP) describes the procedures verifying a Product’s design through appropriate inspection, testing, analysis, and review. This Verification ensures the Product Requirements, which are defined during the Design Input phase of Design Control, have been met.

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    $190.00

  2. Medical Device Design Validation SOP

    Medical Device Design Validation SOP

     This Standard Operating Procedure (SOP) describes the program necessary to validate the design of COMPANY products against User Requirements. This Standard Operating Procedure (SOP) describes the This SOP is part of the COMPANY Design Control Program, as outlined in the Design Control SOP.

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    $220.00

  3. Development Project Initialization and Design Review

    Development Project Initialization and Design Review

    This Standard Operating Procedure (SOP) describes the Design Review requirements associated with a specific design project and is intended to ensure that a design satisfies the requirements for the intended use of a product and meets the needs of the user. This SOP is part of the COMPANY Design Control Program, as outlined in the Design Control SOP.

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    $180.00

  4. Medical Device Design Changes SOP

    Medical Device Design Changes SOP

     This Standard Operating Procedure (SOP) describes the requirements associated with making design changes during the Design Control process.

    This SOP is the essential part of the overall Design Control process.

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    $180.00

  5. Standard Operating Procedure Template - SOP Template

    Standard Operating Procedure Template - SOP Template

     This is an empty SOP template to create site specific standard operating procedures. It contains all relevant section headers of an up to date operating procedure.

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    $19.90

  6. Medical Device - Combination Product SOP

    Medical Device - Combination Product SOP

    NEW! This Standard Operating Procedure (SOP) describes the requirements according to 21 CFR Part 4 for combination products. For the European market, when a device is placed on the market forming a single integral product together with a medicinal product and it is not reusable, it shall be governed by the Medicinal Products Directive 2001/83/EC (MPD) applying the requirements of Annex I to the Medical Devices Directive 93/42/EEC (MDD), as far as safety and performance-related device features are concerned.

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    $229.00

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