Accredited
Test Laboratory
What is the goal of medical device testing?
The primary objectives of tests for the medical sector are patient safety, quality assurance, product safety and compliance with the requirements of the MDR (Medical Device Regulation - EU Medical Device Regulation) and thus its marketability. According to international regulations, the packaging of your sterile and non-sterile medical device should protect your device from damage, contamination and possible loss of sterility.
By selecting suitable standards for packaging tests and medical device tests, you can identify potential weaknesses preventively or analyze them afterwards. Medical device tests are important to ensure the reliability and safety of for patients and users and that there are no risks. The tests support the design and development of medical devices and their packaging. The tests are essential for approval, such as CE marking.
How is the most fitting test method selected?
The appropriate test method is always based on our customers' requirements: You specify the standardized test method and the standards according to which we test your product.
For the approval of your products, we offer accredited services in the field of packaging validation, including process, transport and shelf-life validation. As a certified test laboratory of the ISTA (International Safe Transit Association), we are happy to assist you with our expertise in this area. Of course, we also carry out various physical-mechanical tests on the medical device itself.
Test Methods:
- Accelerated and Real-time Aging
- Seal Strength Test
- Burst Test
- Leakage Test
- Material Test
- Package Validation
- Package Process Validation
- Shelf-Life-Validation
- Functionality Test
- Multiple Reprocessing in RDG & Autoclave
Standards:
- DIN EN ISO 11607-1 and methods from Annex B
- DIN EN ISO 11607-2
- DIN 13097-4
- ISO 9626
- ISO 1135-4
- ISO 3826-1
- ISO 10555-1
- ISO 7864
- ISO 7886-1
- ISO 8536-4
Accreditations of our Test Laboratories
Accredited test laboratory PAConsult
Experience & Expertise
96
Test Methods
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8
Industries
49
Employees
5
Locations
