Molecular Testing solutions for Cosmetics, Cosmetic testing, Microbiome analysis, Microbiome friendly, Species Indentification services, Pathogen Detection

Medical devices are essential when it comes to healthcare and patients well-being. Medical devices testing should ensure safety to diverse & versatile medical devices. Biological, in vitro, chemical, microbiological, stability and physical medical devices testing is offered.

Competitive biological testing for medical devices includes:

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

In the field of in vitro testing, QACS Lab conducts medical devices testing, based on reconstructed human tissue.

  1. We offer standard skin and eye irritation tests.
  2. 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.

Laboratory medical devices testing services concerns product testing during product development for preservation adequacy against microbial contamination.

Laboratory 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

Tests can be included in stability protocols.

Range of environmental factors, temperature, humidity & light generate stability studies for medical devices. Testing evidence services ensure stability and quality of the product to be evaluated.

To document the shelf life of 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

For Medical Device testing, contact us hereemail at info@qacs.gr or give a call at + (30) 210 29 34745