Navigating Medical device testing beyond design and development

Background of navigating testing of medical device

If you ask submitter what is most demanding part at preparation for product registration, you might hear testing. From the review of regulatory affairs, it is called also non-clinical testing, verification, validation, bench testing or performance testing. For developer, testing is derived from design input to be shown as evidence to design output. So it is equivalent to verification and validation (V&V). V&V is required at chapter 7.3.6 and 7.3.7 at ISO 13485.

Validation: Confirmation through provision of objective evidence that the requirements for a specific intended use or application have been fulfilled.

Verification: Confirmation by examination and provision of objective evidence that the specified requirements have been fulfilled.

For authority, testing is oft most important document under strict review, because it demonstrates efficacy, reliability, and safety of medical device. It is an evidence to be compliant with standards and essential requirement. Often the performance data on instruction for use or datasheet is to match with rational testing.

Testing to relevant standards (e.g. IEC 60601-1 series) shall be provided. However there are in many cases of company own method.

The testing at technical documentation is only mini portion of all verification and validation.

Testing = Verification and Validation

The typical testing is

Chemical, physical
Biocompatibility
Software validation
Electrical Safety and Electromagnetic Compatibility (EMC)
Packaging, Stability and Shelf-Life
Sterilization
Usability

International testing can be executed in interested market as

Type testing in China
Usability testing in US
Anatel testing in Brasil
Wireless testing

*in this article we exclude the process validation, animal and clinical testing.

Testing is usually involved by many parties in and out of company as

Testing engineer internal and external
Testing prover and releaser
Technical supporter
Regulatory affairs manager
Risk manager
Product manager
Marketing manager

Don’t forget distributors or sales personals who use the performance data of testing to make subject product competitive at tender and all other sales activities.

Testing can be related to the documents:

Risk management file
Software file
Verification and validation (plan and report)
Design input, design output, design transfer
Marketing material as IFU
Product description

Procedure of product testing

The workflow of testing can be diverse depending with which tool manufacture records design control and where to conduct testing. We just make a basic workflow as show case in this article.

1. Define user needs, specifications

Now we are in design stage. From user needs it deviates to design input and design out (specification). To verify the specification, a testing is needed.

2. Search applicable standard

The best case for a normative reference is an internal standard. Otherwise for individual device, manufacturer or labs have to develop a solid testing method.

3. Draft testing plan with acceptance criteria

Found the method, the testing plan should be written in detail with sample selection, testing set up, testing objectives and instrument and acceptance criteria. Prior to testing, testing protocol should be also prepared.

4. Plan testing project if applicable

Ideally a project for a complex external testing is beneficial. You have to apply for a testing to get a slot in time. After contract a close discussion of testing plan should be exchanged. The resources must be planned precisely. Don’t forget that the testing could fail, think of plan B.

5. Execute the testing

According the testing plan and setting in protocol, a testing is started. It will be accompanied with many rounds of trouble shooting. The output of testing is adjusted and filled testing plan and protocol. Note all anomalies and make picture or videos to remember critical working steps.

6. Evaluate the testing

At the end the testing should be evaluated by different experts. If the testing data is too long, make different annexes as attachment after report. An evaluation helps reviewer later to examine the testing, of course with a distinct “passed”.

For developer the specifications should be frozen depending on the design stage. All related documents as risk management, design control files, instruction for use, label should be updated.

Important regulation and guidance

ISO 11607 series of standards – Packaging safety of terminally sterilized medical devices
ISO 10993-1 series of standards – Biocompatibility testing and evaluation
Human factor and usability engineering, FDA
Recommended Content and Format of Non-Clinical Bench Performance Testing, FDA
Guiding principles for stability research of passive implantable medical devices, China
National Communications Commission, radio wireless testing in Taiwan

Do you know that you should integrate testing plan for registration in early development prior to release instead of reactive testing for registration?

Contact us at any stage from design, development, V&V to technical documentation. We understand engineering, quality management and regulatory affairs.