QMSR Design and Development Controls

ISO 13485:2016 Design and Development

Clause 7.3 - Design and Development
Clause 7.3.1 - General
Clause 7.3.2 - Design and development planning
Clause 7.3.3 - Design and development inputs
Clause 7.3.4 - Design and development outputs
Clause 7.3.5 - Design and development review
Clause 7.3.6 - Design and development verification
Clause 7.3.7 - Design and development validation
Clause 7.3.8 - Design and development transfer
Clause 7.3.9 - Control of design and development changes
Clause 7.3.10 - Design and development files

Design and Development Inputs and Outputs

Design and Development Inputs 

The current QSR requires a manufacturer to document and maintain procedures to ensure that a device’s design input requirements: 

• are appropriate, 

• address the device’s intended use, and 

• address the needs of the user and patient. 

In addition, QSR requirements stipulate that the quality system procedures must have a method to address requirements that are incomplete, ambiguous, or conflict with other requirements. The procedures must be documented, reviewed and approved by designated individuals, and the approval shall be documented.  

ISO 13485 Clause 7.3.3, Design and development inputs, has the same requirements as the QSR but adds more detail to what must be considered and documented during the design inputs phase. Many of these are typically performed during the definition of design inputs in a QSR quality system, but perhaps not specifically mentioned in the QSR. The standard stipulates that inputs must contain: 

• Functional, performance, usability, and safety requirements 

• Applicable regulatory requirements and standards 

• Applicable output(s) of risk management 

• Information derived from previous similar designs (as applicable), and 

• Other requirements that will be essential for the design and development of the new product and processes. 

The requirement to consider information from previous designs recommends a review and consideration of design elements from similar devices to integrate any design aspects that may be applicable to the new product design, as needed.  

Like the QSR, Clause 7.3.3 requires that inputs are reviewed for adequacy and approved. And finally, the clause references another ISO standard that provides additional information for designing usability into the product: ISO 62366-1, Medical devices Part 1: Application of usability engineering to medical devices.  

Design Outputs 

Both the QSR and QMSR require an adequate evaluation and confirmation that design outputs match design inputs, contain or reference acceptance criteria, and specify the outputs that are required for the proper functioning of the device.  

The QSR is focused on the establishment of procedures for design output activities; the QMSR (Clause 7.3.4, Design and development inputs) simply states the requirements, to include documenting and maintaining records from the design output process. 

And the QMSR includes another requirement at the design output stage: to provide appropriate information for purchasing, production, and the provision of servicing. This means that draft component specifications that include sourcing information are developed, draft production processes are established, and any potentially needed servicing of the product is defined and documented. 

Next: Design Reviews