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 Transfer and Changes
Design and Development Transfer
Both the QSR and QMSR require procedures for the transfer of the product to production. The QSR requirement is to ensure the device design is adequately translated to production specifications. The QMSR Clause 7.3.8, Design and development transfer, specifies that the procedures must ensure that before the design is transferred to production the organization must ensure that 1) the design and development outputs are verified as being suitable for manufacturing, and 2) production capability can meet product requirements.
Control of Design and Development Changes
Clause 7.3.9, Control of design and development changes, requires the organization to document procedures to control design and development changes for a device. If there are planned changes to a device, the organization must identify the change and determine its significance to device function, performance, usability, safety, and applicable regulatory requirements.
Before implementation the changes must be reviewed, verified, validated (as appropriate), and approved.
The review must include an evaluation of the effect of proposed changes on constituent parts and product that are in process or have been delivered, the inputs or outputs of risk management and product realization processes.
Design and Development Files
Clause 7.3.10, Design and development files, requires design and development documentation and records to be maintained in a Design and Development File (DDF). The will replace the QSR term Design History File (DHF). There shall be a DDF for each device type or device family.
The DDF shall include or reference records that were generated during the design and development effort to demonstrate conformity to the 1) requirements for design and development, and 2) records for design and development changes.