Test Method Validation in the Development and Manufacture of Medical Devices
Test method validation (TMV) training for medical devices helps ensure that test methods are fit for purpose. TMV is a requirement for medical devices and involves verifying that the test methods produce the desired results.
Successful participants in this training will:
- Know the requirements for test method validation.
- Acquire the know-how for the safe development of test methods, both in your company and with your suppliers.
- Understand the requirements and restrictions for the use of your test equipment and test systems.
- Persons involved in the development and validation of test methods from the areas of development, production and quality assurance
- Manufacturers and developers of medical devices and their suppliers
- Consultants, internal and external auditors
- Overview of the regulatory requirements for TMV (e.g. from MDR, MDSAP and ISO 13485)
- Examples of available directives and standards
- Selection of test equipment, test equipment suitability
- Qualification of test facilities (IQ)
- Repeatability, robustness (gauge R&R)
- Defective Product Detection, Test Method Validation (TMV)
- Statistical methods
- Notes on implementation and documentation in accordance with ISO 13485 including ISO 17025
- Examples and exercises for simple visual or measuring tests
- Examples and exercises for automated test systems
The path of a medical device from the idea to the final application is strictly regulated and appears to be very long. It is necessary to focus on the most important feature of a medical device, namely SAFETY. Safe development and construction is the be-all and end-all. Supervisory authorities, the European Commission, notified bodies and users demand a guarantee that the manufactured medical device is safe according to specified standards and fulfills its purpose. Only then can the product be brought to market. Numerous test methods are used in the development and manufacture of medical devices that serve the safety of the medical devices. Although manufacturers and suppliers invest a lot of effort in testing, defective products in the field occur again and again due to insufficient test method validation. Possible consequences may be loss of resources due to charge accidents or even loss of reputation due to product recalls. The solution is the right test method and its validation in order to avoid errors from the outset.
In this seminar, you will receive an introduction to the regulatory requirements and instructions for the systematic derivation and validation of test methods. We will shed light on the topics of test equipment selection, test equipment suitability, qualification of test facilities and test method validation (TMV). The TMV is in the foreground as objective proof of the suitability of the test method for the detection of non-compliant products. Through practical examples and exercises for supposedly simple test methods (visual, measuring) as well as for automated test systems, knowledge transfer into practice succeeds. The seminar helps you to better understand the strengths and weaknesses of your development and validation of test methods. So that you can keep an eye on safety from the very beginning of the production of medical devices and thus effectively contribute to approval and market success.
Find the ideal test methods for safe medical devices!
Why TMV training is important:
- TMV helps ensure that the medical device is safe and effective
- TMV helps ensure that the medical device meets the intended use
- TMV helps ensure that the medical device is reliable, durable, and of good quality
This is an instructor-led training with specialist lecturers from the TÜV SÜD Academy.
Certificate of attendance from the TÜV SÜD Academy.