cGMP – Design and Development Outputs (SwRS-MecRS-HwRS-FwRS) – ISO 13485:2016 (8) Clause 7

Rami.Azulay June 16th, 2019 Posted by Rami Azulay( ) e-GMP, Requirements Management, Validation and Verification

In the same manner that we have design and development input. We also have design and development output. The result of satisfying the criteria for design input is the design output.  The output will possess risk assessment for the following ;

  • Assembly drawings
  • The specification for raw materials and components
  • Design and process
  • Instruction for installation and service
  • Guideline for the assembly process
  • Specification for labeling and packaging
  • Source code and technical files
  • Biocompatibility studies
  • Results of verification activity
  • Validation activities such as sterility, reliability testing or shelf-life studies and shipping.

 

The design and development output is also known as the first realized product. Depending on the type of product. It could be the first of several lines of assemblies or the first batch of products manufactured. The initial set of the first realized product must undergo evaluation checks. The checks will ensure that the design output requirement is met. Likewise, there will be serial number checks to ensure there is consistency in the process.

Orcanos ALM provides all the tools you need for complete coverage of the design outputs both from the product definition but as well from the change control as risk management according to ISO 14971:2012 with full traceability and impacts analysis tools, all in the same tool.

 

 

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About the author, Rami Azulay

Rami has over 24 years of experience in various software development and QA roles. Using his extensive knowledge of operations and quality, Rami was a main architect of the Orcanos software back in 2005 and later became Orcanos VP sales & marketing. Rami holds an MSC degree in Computer Sciences.

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