Testing

Independent testing of medical devices is being stipulated more frequently by auditors and regulators. Our partner for a wide variety of this test work is Protomed. They have released a brochure indicating how they can help you to prove equivalency to an existing product, or demonstrate the safety and efficacy of your product. MET and Protomed can develope protocols, test designs and products, and present the data to demonstrate the safety and efficacy of your product.

Download the Brochure (787k)

Brand new information is available from MET about the latest in leak test equipment. Downloads are available giving details of the flexible 450 leak test computer for pressure decay testing, and for super sensitive hydrogen and helium leak measuring equipment.

Download - Pressure Decay Tester

Download - Hydrogen Leak Detector

Download - Helium Leak Detector

At MET our product design service is matched by comprehensive test capabilities to prove the function and performance of your medical device. Whether you are in cardiology, laparoscopy or orthopaedics our experts can support your project. Facilities include: bespoke test benches, fatigue and wear testing, pulsatile flow vascular simulation, FMEA analysis, package performance testing and much more.

Medical Device Testing Supports Design

MET’s partner, Protomed, have renewed their web site. The new site details concept development and design services for medical device suppliers. The product design group is very innovative, they have experience with cardiac and vascular devices and their own range on minimally invasive products.

Testing of devices encompasses: FEA studies, fatigue testing, comparative and validation testing, in vivo studies and experimental surgery.

All testing and development services are encompassed by an ISO 13845 quality system

Hydrogen leak testing provides the ultimate sensitivity when integrity testing balloon catheters and other medical devices. The low viscosity of the gas allows the tiniest of leaks to be quantified and located.

Hydrogen leak testing

Details of our vial closure seal testing is now available on a new web page. This equipment complements our tablet blister testing range.

The new web page is here:
Vial Closure Integrity Testing

Low vapour transmission pouches used for IVD or other moisture sensitive products, including dressings which should be kept moist, can be quality controlled by vacuum decay leak testing. The foil pouch is placed into specially designed tooling. Closing the chamber automatically starts the leak test cycle. A vacuum is drawn in a slave chamber. The vacuum is then dumped to the test chamber. As the volume of each chamber is known the resulting pressure will also be known. Any variation from this pressure will be a result of leakage from the test pack.

This type of system is typically calibrated with a specifically manufactured reference leak and validated using perforations of known size.

This method is often not suitable for pouches filled with a gloopy fluid which can mask leaks or enter the leak test machine electronics.

Restraining pouches and other flexible products is an ideal way to allow pressure decay leak testing. The drainage pouch or administration bag is placed between two restraining plates. The plates are porous, so as not to mask any leaks on the surfaces. The leak test machine then internally pressurises the product through a suitable connector and the pressure decay method gives a very accurate measure of any leakage in the product. This type of system is typically calibrated with a specifically manufactured reference leak and validated using perforations of known size.

Ostomy Leak Testing