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 Verification and Validation

Design and Development Verification 

Both the QSR and QMSR reflect the basic requirements of this stage – follow procedures to ensure that design outputs meet design input requirements and maintain records of the design and development verification.  

But the QMSR (Clause 7.3.6, Design and development verification) has additional requirements. First, it requires a documented verification plan specific to the design that is under evaluation. This includes methods, acceptance criteria, and statistical techniques (as required) that include a rationale for sample size.  

Also, if the device will be connected to or interface with other devices, the verification shall confirm that the device outputs match its inputs when the devices are connected.  

Design and Development Validation 

Like the design and development verification stage, QMSR and QSR basic requirements for design validation are essentially the same – follow planned and documented arrangements to ensure the product is capable of meeting requirements for its application or intended use. But where the QSR is focused on the establishment of procedures for validation, ISO 13485 specifically requires the documentation of validation plans, to include methods, acceptance criteria, and, as appropriate, statistical techniques with a rationale for sample size.  

Both QSR and the QMSR require that design validation is performed on representative product – initial production units, batches, or their equivalents. The QMSR requires organizations to document the rationale for their choice of product used for validation. And it stipulates that product shall not be released to the customer before validation is complete. 

Clause 7.3.7, Design and development validation, has a requirement to perform clinical evaluations or performance evaluations. But if you read further, the paragraph states that those activities shall be done in accordance with local requirements. In other words, the need for clinical evaluations is determined by the regulatory agency in the geography where an organization will sell its products. In the U.S. the requirement is the same, based on the risk classification of the product and any special controls. There will be no changes to premarket notification requirements (21 CFR 807), nor will the premarket approval requirements of 21 CFR 814 be changed. 

And like the QMSR verification requirements, if the device will interface with other medical devices its validation activities must include the device under development connected to other interfacing devices. 

Next: Design Transfer and Changes