Medical Device Testing| PAConsult

What is the objective of medical device testing?

The objective of medical device testing is to demonstrate the conformity of the product with regulatory requirements and thereby its marketability. This is achieved through testing in accordance with applicable directives, standards, and specifications, or specific customer requirements. Medical device testing is essential to ensure that products are reliable and safe for patients and users.

The packaging must keep the product undamaged and, in the case of sterile products, maintain sterility until use. This protects patients from potential risks. Medical device and packaging tests serve to ensure that the quality and reliability of the products are guaranteed at all times.

The tests support the design and development of medical devices and their packaging. For regulatory approval, such as CE marking, these tests are indispensable.

What happens during a medical device test?

Stability and transport safety must be validated both for medical device packaging, particularly sterile barrier systems and for the product itself. For this purpose, the products together with their packaging are initially subjected to aging, transport simulation, or repeated reprocessing in accordance with their respective life cycle.

Subsequently, it must be ensured that the medical device and the packaging continue to deliver the required performance. For this purpose, PAConsult offers a wide range of packaging tests in accordance with ISO 11607, as well as physical and mechanical testing for the functional performance of medical devices themselves.

Medical device testing inquiry

In which areas are medical device tests applied?

Medical device testing covers a wide range of disciplines, such as biocompatibility testing, chemical characterization, and functional testing. PAConsult supports you in the field of physical and mechanical testing to ensure stability, transport safety, and functional performance.

Initial tests are already carried out during the design phase to ensure that the device or the packaging meets all required performance criteria. For approval in international markets, the final product including its packaging is validated.

Further tests may be required if there are changes to the device that cannot be assessed through a risk analysis.

Medical device testing inquiry

How do we carry out a test procedure?

PAConsult initiates the test procedure following a customer inquiry. This contains the data of the product to be tested (specimen) and provides information about the underlying standard and the corresponding test parameters as well as the number of specimens.

Based on this information, you will receive an quotation. We support our customers at any time through personal consulation in order to address individual requirements. Optionally, we can create a test or validation plan in cooperation with our customers.

Once your specimen has been received at one of our two test centers for medical devices, we begin the technically precise testing in accordance with specified standards and your requirements. The progress of the test is documented in our raw data.

Once the test phase is completed, you will receive our comprehensive test-report including the results of your specimen as well as a statement of conformity with standards or customer specifications.

Request Medical Device Testing