Verification of Medical Devices
IT security for network-enabled Medical Devices
Verification determines whether you did something right - Validation determines whether you did the right action. We put you on the right track to a safe Medical Device. Together, we will take the right approach to develop the safest Medical Device possible.
Verification, or rather Verification of Medical Devices - what is that anyway?
The Verification of Medical Devices involves examining whether the Medical Device complies with its given specifications. The term is defined, for example, in ISO 9000 as "conformation through the objective evidence that specified requirements have been fulfilled."
Verification documents are the core of Technical Documentation and, together with Validation documents, prove that the essential requirements for the safety and performance of your Medical Devices are met.
EN ISO 13485 makes extensive demands regarding the Verification of development results. The more complex a Medical Device is, the more complex is the Verification. And if it is not effectively planned, the effort involved can quickly exceed what is necessary .
Challenges and questions in the Verification of Medical Devices
You have a set standard of tests that you apply to all newly developed Medical Devices, and now you need to trace the Verifications back to the development inputs.
You have heaps of test reports, and suddenly you have to deliver "one" Verification report because your Notified Body no longer accepts the individual reports.
You urgently need a good Verification strategy to be efficient in your development process, because time is short.
You have the feeling that the existing or planned tests are sufficient, but you lack the evidence?
And what is the difference between Medical Device Verification and Design Verification?
qtec as your partner
Almost all manufacturers have difficulties in defining "appropriate statistical methods with justification
for the sample size". Why are statistical methods needed at all?
Here one can distinguish two main cases:
- Statistical methods are needed to define justifiable sample sizes.
- Statistical methods are needed to interpret measurement results of scattered Medical Device properties and to make a comprehensible decision whether or not a Medical Device property is fulfilled.
The goal of a good strategy is;
- to test as little as possible and
- only as much as necessary.
To optimize tests as far as possible so that several parameters can be tested in one test case. And because documentation is half the battle. So that you can also prove that your Medical Devices are safe and efficient it is important that you possess:
- Clear, well structured test plans
- Complete documentation of the tests
- An evaluation of the results discussed in context.
- Which clinical strategy do I use to evaluate my software as a medical device according to MDCG 2020-1? We know the regulatory requirements.
- Areas: Europe, Worldwide / Updates, New regulations and guidances 31/22
- Life Cycle management tool support in medical technology. DOORS, RQM or ELM - correctly manage requirements, tests, documentation and traceability.
- Areas: Europe, Worldwide / Updates, New regulations and guidances 20/22