‘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 deep knowledge of science and regulation we provide consultation throughout the whole life cycle of a product in order to consistently meet the 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.

Identify all EU Directives applicable to your product
Identify the applicable harmonized standards
Check medical devices against the Essential Requirements (Annex I)
Select and perform the Conformity Assessment Procedure
Prepare a Technical File and implement a Quality Management System
Select a Notified Body and sign your Declaration of Conformity.

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.

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 various biological models with the test material or a suitable extract, under a GLP environment.

Primary test categories used to address the biological endpoints are:

Cytotoxicity testing
Irritation testing
Sensitization testing

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:

a) a proposed material to a clinically established material, and

b) a prototype device to a final device

Chemical Characterization comprises a variety of analytical techniques, in order to identify and quantify materials that may have migrated from the product contact material into the solution of interest. The purpose of this testing is to determine a baseline to the extractable amount of chemical compounds present in and on a medical device and utilize extraction conditions similar to those utilized in biocompatibility determination of similar devices.

Through state-of-the-art equipment and scientific expertise, we provide analytical services regarding:

Degradation products
Leachables & Extractables
Ethylene Oxide Residuals

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

Qualimetrix is GMP approved to perform routine testing and release of APIs, excipients, packaging and final products (chemical and biological). This activity also involves batch release testing, for products manufactured outside of the EU which are planned for importation and release within the European market (EU testing).

The stability of a final product should be monitored according to a continuous and appropriate program that will permit the detection of any stability issue (e.g. changes in levels of degradation products). The purpose of the ongoing stability program is to monitor the final product and to determine that the final product remains, and can be expected to remain, within specifications under the storage conditions indicated on the label.

We provide services on method development and validation of the analytical methods necessary for the control of your finished products. Comprehensive analytical support during the development of drug formulations is also provided.

Our R&D services combine innovative approaches, modern instruments and advanced knowledge in the field of analytical science in order to achieve high performance in terms of selectivity, precision, sensitivity and robustness.

Every method is thoroughly tested to ensure its compliance with regulatory requirements and its ultimate performance and robustness in any laboratory worldwide. Besides development, method optimization is essential in order to obtain top quality data in a shorter time and at lower cost.

Methods are validated in accordance to the current regulation (e.g. ICH guidelines, Pharmacopoeia monographs), and sponsor’s specific protocol. The critical parameters that may affect the method performance are taken into consideration, and the study involves among others the following:

Specificity and selectivity
Linearity and range
Repeatability and intermediate precision
Standard and sample solution’s stability