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Medical Devices

testing dispositivi medici - White Lab

White Lab Laboratories can offer a comprehensive testing and consultancy service to support customers from the design of the Medical Device to its marketing and for its whole lifetime.

Thanks to a Research and Development department composed of a highly-trained team, testing protocols tailored to the needs of each customer can be developed.

To ensure the compliance and safety of the products, our laboratories offer all the industry stakeholders decades of experience and a comprehensive range of in-vitro, in-vivo, and chemical characterisation testing in line with Italian and international applicable guidelines and regulations.

The Quality System of our laboratories complies with the requirements of UNI CEI EN ISO/IEC 17025 standard and the relevant parts of ISO 9001 standard. The Accredia certification and the Good Laboratory Practices (GLP) can be applied to many testing types: in-vivo and in-vitro biocompatibility testing in line with ISO 10993, ASTM, OECD and USP, microbiological testing, and endotoxin identification testing.

Our offer is tailored to any type of Medical Device (class I, IIa, IIb, III), with reference to the classification set out in Annex IX of Italian Legislative Decree No 46 of 24 February 1997 and to the Devices Composed of Substances as defined in Rule 21, Annex VII of EU Regulation No 2017/745 (MDR).

The Preclinical and Clinical Evaluation (in line with MEDDEV 2.7/1 revision 4) allow to draft the necessary Technical Files for the CE marking process and to rule out pharmacological activity. In addition, the Risk Analysis covering all the stages of the product life cycle allows to evaluate the compliance with the compulsory requirements for medical devices and active implantable devices (Directives 93/42/EEC, 90/385/EEC and 98/79/EC and following amendments and additions).

Depending on the characteristics and intended use of the Medical Device, we carry out appropriate evaluations and testing for the validation of FDA reprocessing, both for microbiology and cleanability and the absence of disinfection residues.

White Lab offers full support from the design of the Medical Device to its marketing and for its whole lifetime, with tailor-made testing protocols

Microbiological analysis

The Microbiological tests are aimed at qualitative and quantitative research of microorganisms and sterility control.

Within our wide range of services we offer:

  • Tests of antibacterial activity of plastic, metal, and other materials for various purposes
  • Test of the effecacy of sanitizing agents, disinfectants, sterilants
  • Colony count of aerobic mesophilic microorganisms at 30°C
  • Enterobacteria
  • Total Coliforms
  • Coagulase-positive Staphylococci
  • Moulds
  • Total viable count of microorganisms, yeasts and moulds
  • Test of Sterility
  • Determination of a population of microorganisms on products (Bioburden) and calculation of sterilization dose
  • Validation of extraction method for Bioburden
  • Detection and quantification of bacterial endotoxins (LAL Test)
  • Sterilizability and disinfectability Test
  • Bacteriostasis Test
  • Effectiveness Test of disinfectants, sterilizants and sanitizing agents
  • Challenge Test
  • Barrier Test against microorganisms
  • Barrier Test against viruses
  • Verification of Viral inactivation
  • Typing of colonies
Chemical analysis

Our laboratory can apply, where existing, official methods (UNI, IRSA, ISO, EPA, FDA, etc.) for the qualitative and quantitative research of substances such as metals, additives, plasticizers, phthalates, residual monomers, VOC, waste processes cleaning or sanitizing disinfection and sterilization. Biochem provides also the tests required for nebulizers by the various International Standards.

Within our wide range of services we offer:

  • Physical-chemical testing in line with the United States Pharmacopoeia (USP)
  • Chemical testing on Medical Devices in line with the European Pharmacopoeia (Ph. Eur.) and the United States Pharmacopoeia (USP)
  • Validation of packaging and packaging systems for sterile Medical Devices (ISO 11607), Dye penetration, Tensile strength
  • Accelerated ageing (ISO 11607, ASTM F1980, ASTM F1608)
  • Validation and control of Cleaning & Clean Room Processes in line with ISO 14644 and ISO 14698
  • Testing Nebulising Systems in line with ISO 27427, EN 13544 and FDA: Particle sizing, Output, Output Rate, VOCS, PM10, PM2.5
  • Polymer Migration testing for materials in contact with food (FDA)
  • Testing Heavy Metals (94/62/EC)
  • Chemical migration testing in line with FDA, EU Regulation No 10/2011, Italian Ministerial Decree of 21/03/1973
  • Identification and testing of Phthalates and Plasticisers (Decree of the Italian Minister of Health No 538 of 17/12/1999, Directive 2007/47/EEC)
  • Identification and testing of Sterilants, Chemical Residuals and Leachable Substances

Would you like to receive more information or schedule a customised consultation for your company? Please, fill out the form and we will get back to you as soon as possible.

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