Design Control Procedures/Forms (SYS-008)

design control SOP Design Control Procedures/Forms (SYS 008)

 This procedure package includes three documents: 

 1. Product Development Procedure

Purpose – The purpose of this (10)-page procedure is to ensure that product is developed in a systematic way, ensuring that risk control measures are incorporated in the design, that all design outputs are verified against specifications and validated against user requirements, and that regulatory and standards requirements are fulfilled.

Scope – This procedure covers design and development of new medical devices, including their packaging and labeling, and to modifications and upgrades of existing devices. This procedure applies from the approval of the initial design.

This procedure is not applicable to research activities that precede design and development…

2. Design Review Meeting Form

3. Design Requirements Matrix

Please note: This product will be delivered to the email address provided in the shopping cart transaction. After the transaction is verified, please check your email for the download. 

design control SOP Design Control Procedures/Forms (SYS 008)
Design Control Procedures/Forms

This procedure package includes three documents

Price: $299.00

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 To view all available procedures click here

To review a sample Medical Device Academy procedure click below:

managment review sample SOP Design Control Procedures/Forms (SYS 008)

 

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