Medical Device Validation.

Process Validation is a necessary requirement in the development and manufacture of every medical device. Process Validation is expected by the US FDA, the EU Directives, Health Canada, the Australian TGA, etc..

– The US FDA CFR states: “Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures”

– International standard ISO 13485, applied when complying with the European Device Directives state: “The organization shall validate any processes for production and service condition where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered”

– In addition process validation helps to assure product quality and reliability, process capability, and confirms the efficacy and “fitness for use” of the delivered product.

When should a process be validated?
The decision tree shown is developed from the IMDRF guidelines on Validation versus Verification. Note: IMDRF (International Medical Device Regulators Forum)

How do I know if a process cannot be fully verified?
If clinical or destructive testing is necessary to show the process produces the desired result or product.

For example: Testing package seals.


Where routine end-product testing:

i) does not examine all quality attributes of the finished device, or

ii) has insufficient sensitivity to verify the desired safety and efficacy of the finished product.

For example: visual examination of a weld.



Guidance is provided by the IMDRF on the approach to Validation.
In performing validation, the following steps should be considered.

Validation team formation.
Consideration should be given to establishing a multi-functional validation team. The justification for the team being that validation decisions maybe more comprehensively assessed, performed and reported, than may arise with an individual responsibility approach to validation. The team also encourages multi-functional representation into validation activities. Suggested representatives of the validation team may come from: Quality Assurance, Production, Regulatory Affairs, R&D, Procurement, Materials, Engineering, etc..

Plan the approach to the Validation activities.
The validation team will need to operate to a validation plan. Many organizations will develop and maintain a Master Validation Plan, which will detail validations to be performed, the validation schedule, planned revalidations, validation methods to be applied, etc..

Etc, etc..


Validation expectations.
The objective is to validate the reproducibility and consistency of a process.


– Validation of the entire fully defined process is carried out using validated equipment.

– A widely applied approach is that validation is performed at least 3 times, under established procedures.

– The process must successfully and consistently meet all acceptance criteria at all steps over each consecutive validation.


When validating a process, assume the worst case. The objective is to ensure that the process is acceptable in the extreme case.


Processes need to be clearly described:

– All equipment needs some form of identity, code number, construction, operation capacity, actual operating range.

– Processing parameters must be sufficiently detailed to permit complete reproducibility (time period, pH, volume, temperature, etc.)

– There must be clearly defined specifications at each step.


Very important:

– Specifications for a process undergoing validation must be pre-determined.

– There must be appropriate & capable equipment available, so that all critical processing parameters for which specifications have been defined, can be confirmed during the validation study.


Medical Device Validation: