Medical Device Testing
We have a totally up to date knowledge of, understanding of and adherence to the pertinent regulations and standards stipulated by the FDA, the European Medical Device Directive, ISO 11607. We also understand that our clients successful compliance may require a combination of these and other relevant regulation depending on where in the world the product is to be distributed .
As we operate in this area all day everyday our knowledge is well informed and as up to date as possible regarding all the testing requirements and standards.
- Environmental Testing
- Transportation Testing
- Dye Penetration
- Bubble Leak Testing
- Vacuum Testing
- Burst Testing
- Peel Testing / Seal Strength
- Microbial Challenge Testing
- Cold Chain Testing
- Accelerated and Real Time Aging
Quick Links
Please Note: The following links will lead to external webpages
ISO 11607-1 Packaging for terminally sterilized medical devices
ISO 9626 Stainless Steel needle tubing for the manufacture of medical devices
ISO 10555-1 Sterile, single-use intravascular catheters -- Part 1: General Requirements
ASTM D882 Standard Test Method for Tensile Properties of Thin Plastic Sheeting
ASTM D3078 Standard Test Method for Determination of Leaks in Flexible Packaging ny Bubble Emission
