Medical Devices

To test your medical devices and establish that they are safe to use, we offer dedicated quality testing services. QACS Laboratory specialises in biological, in vitro, chemical, microbiological, stability and physical testing of medical devices.

Why medical device testing is important

Medical devices are essential when it comes to the healthcare and wellbeing of patients.

Due to the diversity and versatility of the medical device sector, you need reliable quality testing services to ensure that your medical devices are safe to use.

Which tests we perform

We perform a wide range of tests to ensure that your medical devices are safe and reliable.

We offer competitive services for biological evaluation of medical devices.

Our services include testing for:

  • Cytotoxicity
  • Sensitization
  • Irritation or intracutaneous reactivity
  • Systemic toxicity
  • Subchronic toxicity
  • Genotoxicity

In the field of in vitro testing, we conduct extremely reliable tests, based on reconstructed human tissue.

We offer standard skin and eye irritation tests.

We also carry out in vitro irritation studies on final products or raw materials that come into contact with various mucous membranes, such as:

  • Oral cavity (oral or gingival tissue viability for oral products)
  • Human airway (nasal and inhalable products)
  • Female intimate area (vaginal epithelial tissue for intimate area products)

We offer a wide range of physicochemical and analytical services on starting materials and finished products.

The tests we conduct include:

  • Chemical analysis and assays
  • Method development, validation and identification
  • Quantification of degradation products
  • Extractables and leachables studies
  • Testing for traces and impurities

All the tests may be included in stability protocols.

We have also invested in state-of-the-art instruments and equipment, including LC-MS/MS, HPLC, GC, GC-MS, ICP-MS and AAS.

We test your products during product development for preservation adequacy against microbial contamination.

Our testing services include:

  • Microbial enumeration of raw materials and finished products
  • Challenge tests (based on both the European and US Pharmacopoeia reference standards)
  • Validation protocols and reports

All the tests may be included in stability protocols.

In stability testing we provide evidence on how the quality of your devices varies over time under the influence of a range of environmental factors, such as temperature, humidity and light.

To document the shelf life of your medical devices, we conduct stability studies that include different storage conditions of temperature and humidity (both ICH and non-ICH conditions). The devices are tested at regular intervals.

We also offer ICH photostability testing to support:

  • Product photostability
  • Container compatibility
  • Packaging materials and labels

We offer a wide range of services to test the strength, the brake load or even the inhaler performance of a device or its container.

The tests we conduct include:

  • Extrusion force of pureed products
  • Hardness and strength testing
  • Film integrity for seals and packaging
  • Cake strength
  • Spread force
  • Evaluation of inhaler performance