Medical Device SOP Package

Availability: In Stock

Regular Price: $2,980.00

Special Price: $2,500.00

Regular Price: $2,980.00

Special Price: $2,500.00

Quick Overview

This Medical Device SOP Package contains the most important SOPs of a Medical Device Quality System.


The package consists out of 17 standard operating procedures and related forms.


All templates are immediately downloadable after payment as Microsoft Word files and after personalization ready for implementation.

Medical Device SOP Package

Double click on above image to view full picture

Zoom Out
Zoom In

More Views

Details

The package contains following SOP Templates:

 

Design Control SOP

This Design Control Standard Operating Procedure (SOP) is ready to use and meets the expectations of a structured development by guiding the design efforts through well defined input and output phases. The 11-page SOP only needs some minor manufacture or design center specific modification before it can be used for your development.

 

Design and Development Plan

This Medical Devices Development Plan describes in detail all essential steps to be considered prior to start the development of medical devices and is in alignment with current FDA and EMA expectations.

 

Medical Device Design Inputs

This Standard Operating Procedure (SOP) describes the Design Input which is part of the Design Control process by which the activities associated with the planning, design, and development of a new medical device are controlled and documented.

 

Hazard Analysis SOP

This Standard Operating Procedure (SOP) describes in detail all the key steps to implement for a consistent, reliable and effective Hazard Analysis Program. This program is a requirement by the agencies not mattering if FDA or EMA. It is essential to identify, mitigate and control risks associated with the development of medical devices.

 

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.

 

Medical Device Design Outputs

This Standard Operating Procedure (SOP) describes the procedures for documenting the Design Outputs corresponding to each Design Input for Product development within the Design Control process. This will also allow for planning of the Verification of the Outputs.

 

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.

 

Clinical Evaluation for Medical Devices in Development

This Standard Operating Procedure (SOP) describes the individual steps and process necessary to comply with the Clinical Evaluation for medical devices. This SOP applies to all Medical Devices under development after concept and feasibility studies are completed. Demonstration of conformity is requested by the Council Directive 93/42/ECC, Annex I, with the relevant essential requirements, which include a clinical evaluation in accordance with Annex X.

 

Human Factors Engineering - Usability

This Standard Operating Procedure (SOP) describes the Human Factors Engineering and Design Validation process applied throughout the development of medical devices. The aim of the process is to analyze, specify, design and validate the characteristics of a medical device related to its use in order to achieve USABILITY.

 

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.

 

Design History File (DHF) SOP

This Standard Operating Procedure (SOP) is ready to use and meets expectations of 21 CFR 820 for establishing a structured Design History File (DHF). The 8-page SOP only needs some minor modification before it can be used as the backbone of the documentation needed during design control.

 

Design Transfer SOP

Design transfer activities during the design and development process ensure that design and development outputs are verified as suitable for manufacturing before becoming final product specification. This Standard Operating Procedure (SOP) for the medical devices design transfer is ready to use and meets expectations of 21 CFR 820 for the transfer from development to manufacturing. The 9-page SOP only needs some minor modification before it can be used by your company as the basis for a successful design transfer in the overall scope of design control.

 

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.

 

Management Review for Medical Devices

This Standard Operating Procedure (SOP) defines and describes the Management Review process, to monitor and verify the implementation of the Management System. This assures the sustainability, suitability and effectiveness of the whole Quality Management System for medical devices and its compliance to satisfy ISO 13485 and 21CFR 820.

 

Risk Management Process

This Standard Operating Procedure (SOP) describes in detail all the key steps to implement a reliable and effective Risk Management Program. This program is a requirement by the agencies not mattering if FDA or EMA. It is essential to identify, mitigate and control risks associated with the development medical devices.

 

Compliance Checklist CFR 820

Are you in compliance with the 21 CFR 820 requirements? This check list can be used to identify gaps in your Quality Systems. The checklist is guiding you with relevant questions through all sections and requirements of the 820. It can be used as internal audit aid or as a questionnaire for external suppliers and contractors.

 

FMEA Failure Mode and Effect Analysis

This SOP applies to all medical devices that are approved for Product Development as well as to the personnel responsible for associated FMEA activities and working under Design Controls for medical devices.

 

All these SOPs have been continually developed over the last years and partially inspected by many health authorities of customers that have purchased our sop templates.

 

Size and Format: 

  17 Files as  Microsoft Word (2003)

Product Tags

Use spaces to separate tags. Use single quotes (') for phrases.

Write Your Own Review

You're reviewing: Medical Device SOP Package