Accredited
Test Laboratory
What is the goal of medical device testing?
The aim of medical device testing is to prove the conformity of the product with the legal requirements and thus its marketability. This is done by testing in accordance with guidelines and standards or specific customer requirements. Medical device tests are important to ensure that the devices 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. Like this, patients are protected 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. The tests are essential for approval, such as CE marking.
What happens during a medical device test?
Stability and transport safety must be validated in medical device packaging, in particular sterile barriers, as well as for the device itself. For this purpose, the devices and their packaging are first subjected to aging, a transport simulation or multiple reprocessing in accordance with their respective life cycles.
It must then be ensured that the medical device and the packaging continue to provide 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 tests for the function of the medical devices themselves.
In which areas are medical device tests used?
Medical device tests cover a broad field, such as biocompatibility testing, chemical characterization and functional testing. PAConsult supports you in physical-mechanical testing to ensure stability, transportation safety and functionality.
Initial tests are carried out as early as the design phase to ensure that the device or packaging meets all the required performances. The final medical device with packaging is then validated for approval on international markets.
Further tests may be required if there are changes to the device that cannot be assessed via a risk analysis.
How do we carry out a test procedure?
PAConsult starts the test procedure after 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 those, you will receive an quotation. We support our customers at any time in a personal meeting to address individual requirements. If requested, 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 products, we start the precise testing in accordance with specific standards and your specifications. The progress of the test is documented in our raw data.
Once the test phase is complete, you will receive our comprehensive report with the results of your specimen and a statement of conformity with standard or customer specifications.
Accreditations of our Test Laboratories
Accredited test laboratory PAConsult
Experience & Expertise
96
Test Methods
+
8
Industries
49
Employees
5
Locations
