What are the Outputs of Design and Development

iso 13485 outputs

The ISO 13485 standard requires the medical device company to define expected outputs at the end of any development stage. Design and development outputs are mean to:

  • meet the input requirements for design and development.
  • provide appropriate information for purchasing, production, and service provision.
  • contain or reference product acceptance criteria.
  • specify the characteristics of the product that are essential for its safe and proper use.

Outputs as criteria

Design output is a drawing, specification, or manufacturing instruction. It describes parts, pieces, and components of the medical device. The first requirement is the outputs have to be verified by the input requirements for design and development. The design outputs will be realized in terms that can be verified, validated, and proved for compliance against design input requirements. In the plan of the design and development, the sources that need to be submitted to the processes as inputs are defined. The sources can be the following – employees, training, customer requirements, regulatory requirements, documentation, etc. The results of these sources will be referred to as inputs. On various levels, the review will be done:

  • Regulatory – if the regulatory requirements were referred and implemented
  • Safety – if the safety issues were covered
  • Performance – if the performance requirements are achieved
  • Functionality – if the functionality requirements are applicable

The design outputs have to be reviewed and approved before their release for use for the next design stage. The review is intended to be done at strategic points during the development processes, and it will ensure an output complies.

The objective of the outputs is to create conditions for the product to be accepted or rejected. Conditions are a base for evaluation or expected results for a reference point against which the product can be evaluated. This will help in the later stages of production processes. The outputs will be planned to verify they are accepted at the end of the design processes.

The ISO 13485 standard requires medical device companies to protect and warn the user or patient if any crucial product characteristics might pose a threat to the user or patient by using the medical device. They are obligated to identify those characteristics and provide the appropriate outputs to resolve these hazards or instruct the user in using the medical device properly and safely.

The outputs have to be applicable and deliver the appropriate information for later provision stages. The purpose is to ensure the outputs will be usable for the realization processes of the product, like production, service provision, and purchasing. The appropriate and applicable information can be used as inputs in these processes. It is necessary to plan activities for the production to realize the product. The definition should include the forms and tools required to deliver the information.

As required from the ISO 13485 standard, any output of design and development stages has to be documented. The standards do not specify the format. The main goal of the records is to show that each development stage was led according to the design requirements. As part of the quality records, the organization will include the design and development outputs and it will be submitted to Control of records as required.

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