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The design and development process can be excluded from the certification to ISO 13485:2016.There is no conflict to implementing design in ISO 13485:2016 if you are already have ISO 9001:2015 certification. Since ISO 13485 expects procedures, the documentation of the design process is a bit more direct. You shall have a procedure for design and development. The elements of the process that shall be documented are:
• Plan the design and development
• Define the design inputs
• Define the design outputs
• Hold design reviews at suitable stages
• Perform verification and validation as appropriate
• Have a procedure for the transfer of the design to manufacturing
• Control changes
• Maintain files for each medical device type
The major differences between the two standards are:
• ISO 13485 expects changes to the plan and requires that changes will be documented
• ISO 13485 requires the designers to be competent
• ISO 13485 requires a medical device file for each family of product.
• ISO 13485 requires defined responsibilities and authorities
• ISO 13485 requires traceability of outputs from inputs
• ISO 9001 specifically addresses the control of interfaces between persons involved in the design
• ISO 9001 specifically addresses involving customers and suppliers in the design process
ISO 13485 has specific planning documentation requirements. Before you start you should have:
• Identify the stages and the necessary design review points
• Define the verification, validation and transfer activities to progress to the next stage
• Define who has what responsibility and authority
• Ensure traceability of the outputs back to the inputs
• Identify the resources needed, including competency
After the project is planned, and frequently in conjunction with planning the design inputs need to be defined. This is a place to ask customers and look at supplier surveys. Inputs should include:
• Functional, performance, usability, safety requirements considering the intended use
• Applicable regulatory requirements and standards
• Risk management outputs
• Information derived from previous or similar designs
• Anything else needed to design the product and production process
After the list of inputs has been defined they must be reviewed for:
• Complete
• Unambiguous
• Able to be verified or validated
• Not in conflict with each other

The design outputs are straight forward:
• Meet the input requirements
• Provide the information for purchasing and production
• Contain or reference product acceptance criteria
• Specify the characteristics of the product essential for safe and proper use
• Be in a form suitable to verify against design inputs
• Approved prior to release
In between the defining the design inputs and producing the design outputs, the design will be reviewed at intervals defined in the design plan. The purpose of the design reviews are to:
• Evaluate the ability of the results of the deign process to meet requirements
• Identify and propose necessary action
In the design reviews and at the completion of the project, the design must be verified and validated. The purpose is to ensure the design outputs have met the design inputs. The verification and validation must:
• Design outputs meet design inputs
• Have documented plans including method, acceptance criteria and statistical techniques and sample sizes
• If intended to be connected to or interface with other medical devices, confirm the outputs meet the inputs when connected /interfaced.
• Validations must be on representative products
• Validate that regulatory requirements have been met and undergone clinical trials
• Validation must be completed prior to release to the customer
• Records of the results and conclusions and necessary actions must be documented
Once the design is verified and validated, the design process is not completed. The design must be documented for the transfer to manufacturing and the suppliers. This is the generation of drawings, specification, production plans, test methods. The design team is responsible to confirm production is capable of producing the product to specifications and within tolerances.
Once the design is in production, the design team is not finished. There must be procedures to control design changes. The design team should be looking at the impact on:
• Function
• Performance
• Usability
• Safety
• Regulatory requirements
Changes shall be:
• Identified
• Reviewed
• Verified/validated
• Approved
• The effect on constituent parts and product in process or delivered
• Risk
As defined in section 4.2.3 a medical device file shall be maintained for each medical device family and include or reference records to demonstrate conformity to requirements and records of design change.
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