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

From Design Control to Design and Development

Both the QSR and QMSR have the same design and development phases of planning, inputs, outputs, verification, validation, transfer, and design changes. All of the 21 CFR 820.30 Design Control requirements are covered in Clause 7.3 of the ISO 13485 standard, in addition to other specified tasks that must be completed for each phase.  

In general, the QMSR design and development clause places and emphasis on risk management, usability engineering, and design and development validation, and has some vocabulary changes for QSR definitions. 

Vocabulary 

Rather than only using the word “design,” as in the QSR, information related to the product design in the QSR are worded “design and development.” This indicates that rather just focusing on the design of the device, these regulations extend to the development of the design and the product. 

The term “manufacturer” is now “organization.” This is important because some process components may be performed at offices other than manufacturing, or by external parties to the manufacturer, such as a design firm. And the requirements apply to them as well. 

And design-related documentation, including records, will no longer be maintained in a Design History File (DHF). Instead, they will find a home in the Design and Development File (DDF).  

See the QMSR Definitions and Vocabulary page for additional QSR-to-QMSR vocabulary changes. 

General 

The QSR mentions which types of devices are required to be designed according to design control (all Class III, most Class II, some Class I). The QMSR includes this information in 21 CFR 820.10(c), design and development controls.   

ISO 13485 Clause 7.3.1, General, simply states that the organization must document procedures for design and development. In the QSR this requirement was stated at each phase; in the standard it is mentioned once and meant to apply to all design and development clauses. 

Design and Development Planning 

The current QSR requirements for the design and development planning phase are to establish and maintain plans for product design and development, including the identification of interfaces between groups that combine to produce design inputs. And as design and development progresses, those plans must be reviewed, updated, and approved as needed. 

ISO 13485 Clause 7.3.2, Design and development planning, does not specifically mention the QSR requirement to define interfaces between groups during the process. However, if a manufacturer documents responsibilities and authorities throughout the design and development process, and the process itself, interfaces between groups should be apparent. Clause 7.3.2 provides additional detail regarding activities in upcoming design and development phases: 

• Design and development review(s) needed and at which stages of development 

• Planned verification, validation, and design transfer activities  

• Responsibilities and authorities (plural, meaning all that are applicable) for design and development (the entire process) 

• The methods that will be used to ensure traceability of outputs to inputs, and 

• The resources that will be needed for the design and development processes must include the requirements necessary for personnel competence. 

The planned requirements shall be documented during the design planning phase, before proceeding to the other design and development phases. 

Next: Design Inputs and Outputs