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7.3 Design & Development (ISO 13485:2016) (7.3.7 Validation (Plans to…
7.3 Design & Development
(ISO 13485:2016)
7.3.1 General
Document procedures
7.3.5 Review
Evaluate results
Identify & propose necessary actions
Maintain records of review results & any necessary actions
7.3.3 Inputs
Regulatory requirements
Output(s) of risk management
Functional, performance, usability & safety requirements
Information derived from previous similar designs
Other essential requirements
Maintain records of inputs relating to product requirements
7.3.4 Outputs
Provide information for purchasing, production and service provision
Contain/reference product acceptance criteria
Meet inputs
Specify essential product characteristics
Maintain records of D&D outputs
7.3.8 Transfer
Document procedures for transfer of outputs to manufacturing
Ensure outputs are verified as suitable for manufacturing before becoming final production specifications & production capacity can meet product requirements
Record results and conclusions of the transfer
7.3.10 Files
Maintain a file for each medical device type/family
File to include/reference records:
Generated to demonstrate conformity to requirements
For changes
7.3.9 Control of Changes
Before implementation, changes shall be:
Verified
Validated (as appropriate)
Reviewed
Approved
Review of changes to include:
Inputs/outputs of risk management
Product realization processes
Evaluation of effect of changes on constituent parts & product in process/already delivered
Maintain records of changes, their review & any necessary actions
Document procedures to control D&D changes
7.3.7 Validation
Plans to include:
Acceptance criteria
Statistical techniques with rationale for sample size
Methods
Conducted on representative product
Performed in accordance with planned & documented arrangements
Perform clinical evaluation/performance evaluations of the medical device
Confirm that specified application or intended use have been met when connected/interfaced (if intended use requires medical device to be connect to/have an interface with other medical device(s))
Maintain records of validation results and conclusions & necessary actions
Completed before release for use of product to the customer
Record rationale for choice of product used for validation
7.3.6 Verification
Performed in accordance with planned & documented arrangements
Plans to include:
Acceptance criteria
Statistical techniques with rationale for sample size (if appropriate)
Methods
Confirm that outputs meet inputs when connected/interfaced (if intended use requires medical device to be connect to/have an interface with other medical device(s))
Maintain records of verification results and conclusions & necessary actions
7.3.2 Planning
To document:
Resources needed
D&D stages
Methods to ensure traceability of outputs to inputs
Review(s) at each stage
Responsibilities & authorities
Verification, validation & design transfer activities at each stage