‘Medical device’ according to COUNCIL DIRECTIVE 93/42/EEC means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

  • diagnosis, prevention, monitoring, treatment or alleviation of disease,
  • diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
  • investigation, replacement or modification of the anatomy or of a physiological process,
  • control of conception,

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.

Using our experience and knowledge of science and regulation we provide consultation throughout the whole life cycle of a product in order to consistently meet the regulatory requirements.

In our well-equipped testing facilities, we offer an extensive range of Biocompatibility studies under GLP environment that are framed by a biological risk assessment under 10993-1.

We offer a full range of materials assessment by chemical characterization and toxicological risk assessment, using instruments and software of the latest technology.

Services we offer

Biological safety evaluation

The biological evaluation of any medical device is performed as a part of the biological risk assessment process. A series of well justified and documented steps are performed in order to evaluate the data that could be generated from any available source.  At the end of this thoroughly planned investigation, the appropriate biocompatibility tests are selected and performed. A Biological evaluation plan (BEP) and the corresponding report (BER) are provided.

The evaluation of the biocompatibility should be appropriate to the intended use of the component material of the finished product. We offer in vitro and in vivo studies, where appropriate and alternative non-animal in vitro screening studies. These biocompatibility tests challenge the test material or a suitabable extract with various biological models, under a GLP environment.

Primary test categories used to address the biological endpoints are:

  • Cytotoxicity testing
  • Irritation testing
  • Sensitization testing


Chemical characterization

Consideration of the chemical characterization of the materials from which a device is made is a necessary first step in assessing the biological safety of the device. It is also important in judging equivalence of:

  1. a proposed material to a clinically established material, and
  2. a prototype device to a final device

Chemical Characterization comprises a variety of analytical techniques, in order to identify and quantify compounds that may have migrated from the product contact material into the solution of interest.

The primary objective of extraction testing is to estimate and assess a “worst-case” chemical release by obtaining an extractables profile that is at least as comprehensive as a device’s leachables profile (i.e. includes all leachables as extractables at levels equal to or greater than the concentrations of leachables). This “worst-case” profile that overestimates the actual exposure during use (i.e. leachable’s profile) provides an added margin for uncertainty in the toxicological risk assessment and can be appropriate in many circumstances. However, in cases where the quantity of any extractable presents a potential safety hazard in the light of its estimated clinical release, a more accurate estimate of actual exposure should be established by means of leachables testing.

Analytical services include quantitation/identification of:

  • Degradation products
  • Leachables & Extractables
  • Ethylene Oxide Residuals

Structure elucidation of unknowns and toxicological risk assessment are also included in our service portfolio.

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