Intelligent Life Services

The TOP laboratory offers an integrated platform for studies of leachables and extractables performed with the most advanced methods completed by toxicological evaluations:

Leachables and Extractables studies
Chemical characterization studies on medical devices are performed within a quality management system and in accordance with GLP (good laboratory practice). The analyses are performed following the reference guidelines for the biomedical sector (e.g. ISO 10993-1, ISO 10993-12, and ISO 10993-18). In particular, instrumental techniques combined with mass spectrometry in high and low resolution are used in order to evaluate the chemical release of the medical devices.

Toxicological Risk Assessment (TRA)
The data collected from the chemical characterization report are used for the toxicological risk evaluation in order to define the safety profile of the products in accordance with the ISO 10993 – 17 standard. Finally, safety is evaluated based on the release of the organic and inorganic compounds identified and subsequently quantified considering the intended use of the medical device.
In the European and non-European regulatory context (US and China), the toxicological risk assessment is a fundamental aspect for biomedical companies.

The Regulation for Medical Devices (MDR) 2017/745 and the applicable guidelines place more and more importance on:

• The Clinical Evaluation of medical devices in order to demonstrate and support their safety and performances, for product certification purposes.
• Post-market surveillance (PMS) and evaluation of collected data.

The Clinical Evaluation Plan (CEP) and the Clinical Evaluation Report (CER) are the documents reporting the Clinical Evaluation process and its conclusions.
These documents are drafted in accordance with MDR 2017/745 and applicable MDCG guidelines and include the following elements:

• Analysis and evaluation of the State of the Art related to the medical device under evaluation and respective generally accepted clinical practice.
• Critical interpretation of the biocompatibility and clinical data available for the specific product or other marketed products for which it is possible to demonstrate equivalence with the device under evaluation.
• Evaluation of data deriving from PMS activities.
• Evaluation of the residual risks related to the use of the device under evaluation and analysis of the benefit/risk ratio.

The purpose of the CER is therefore to document all the data supporting the conformity of the device with the General Safety and Performance Requirements when used according to its intended use.
CEP and CER are documents required for all medical devices sold in Europe regardless of the risk class and are part of the Technical File Documentation, which will be evaluated, when the Regulation so specify, by the Notified Bodies, in order to obtain the Conformity Certificate (CE). CE mark is an essential requirement for placing the product on the European market.

ISO 10993-1:2018 introduced the BEP as an essential step in the biological evaluation of medical devices. The BEP has now developed into a risk analysis process which can been combined with the chemical characterisation requirement. They can lead directly to a positive Biological Evaluation Report (BER) or to the specification of further testing prior to reporting positively.
If the BEP indicates that all the materials have good evidence of safety, that processing has no possibility of changing this safety, that there is no risk of contamination and that the combination of materials is not toxic, then the Biological Evaluation Report (BER) can conclude that no further testing is required. If the conclusion is that safety has not been proven the BEP should propose a test programme to satisfy the endpoints found in the ISO 10993-1 biocompatibility matrix.
BEPs carried the aim to reduce test requirements to the absolute minimum. When testing to satisfy end points is needed the chemical testing will be considered above the biological testing. The chemical extractables analysis combined with a Toxicological Risk Analysis can cover all endpoints that don’t investigate a local effect.

The new usability room is part of the TPM expansion project (which includes further interventions co-financed by the Region) and currently the service is available in a room outside the TPM.
Human Factors focus on people and their interaction with products, equipment, skills, procedures, work environments and everyday life.
Usability emphasizes people (operators) and how the design (engineering) of medical devices influences them. In order to better match the abilities, limitations and needs of users, Human Factors studies improve the health products used by healthcare professionals and the environments in which these objects are used for safe use.
The goal is to ensure that the user interface of the device is designed in such a way that usability errors that occur during the use of the device that could cause harm are eliminated or reduced as much as possible.
Usability is integrated platform, consisting of a suitably equipped area and specially trained personnel, that allows a hospital environment to be reproduced for the purpose of carrying out usability studies that are also necessary for product certification or registration in accordance with industry regulations:
EUROPEAN STANDARDS
IEC 62366-1:2015 Medical Devices – Part 1: Application of usability engineering to medical devices
AMERICAN STANDARD
Applying Human Factors and Usability Engineering to Medical Devices – Guidance for industry and Food and drug administration Staff (February 3 2016)
The agreement signed between Democenter-Sipe Foundation and AUSL of Modena, aims to facilitate scientific collaboration for research projects in the clinical field, within the biomedical and health technologies sector, allowing integration between medical health personnel, researchers and industry.