1
Usability Engineering in the innovation framework of medical devices
The new usability room is part of the TPM expansion project which includes further interventions co-financed by the E. Romagna Region .
Human Factors focus on people and their interaction with products, equipment, skills, procedures, work environments and everyday life.
Usability puts emphasis on people (operators) and the way in which the medical devices design influences them. In order to best combine skills, limitations and needs of users, studies applied on human factors improve the health products used by health professionals and the environments in which these objects are used for a more safe use. The goal is to ensure that the device’s user interface is designed in such a way that usage errors that occur during use of the device that could cause damage are eliminated or reduced as much as possible.
Usability is an integrated platform, consisting of an adequately equipped area and specifically trained personnel, reproducing an hospital environment in order to perform the usability studies necessary for certification or product registration in accordance with industry regulations:
EUROPEAN LEGISLATION
IEC 62366-1: 2015 Medical Devices – Part 1: Application of usability engineering to medical devices
AMERICAN LEGISLATION
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 clinical research projects in the biomedical and health technologies sectors, allowing integration between health care personnel, researchers and the industrial world.
2
Support for CE certification and registration of EU
The TOP laboratory offers an integrated platform of leachables and extractable tests with the most advanced methods completed by toxicology and medical safety studies:
- Leachables and extractables according to USP and ISO 10993: 12 and ISO 10993: 18 standards
- Toxicological Assessment Report
- Toxicological Risk Assessment Report
Studies of toxicological assessment to define the safety profile of products in accordance with ISO 10993: 17 and ISO 10993: 18 standards. Safety is assessed through the identification and evaluation of supplies, additives, colorant processing aids and the evaluation of their toxicological risk and exposure of the finished product.
In the European and extra-European regulatory context (US and China) in which the companies of the biomedical sector operate, the toxicological risk assessment is one of the most important parts.
3
Clinical Evaluation Report (CER)Medical Device Safety Assessment
The applicable regulations and the New European regulation MDR are creating increasingly importance to:
- Safety assessment (Clinical Expert Report for product certification).
- Post marketing monitoring and assessment.
The Clinical Evaluation Report (CER) is the clinical evaluation document based on MEDDEV 2.7 / 1 rev. 4: 2016.
The CER certifies the conclusions of a medical device clinical evaluation and includes the following elements:
- Critical interpretation of biocompatibility data and clinical data available on the specific product or on substantially equivalent products in the market.
- Identification and critical evaluation of toxicology and human exposure data in products, materials and components.
- Health risk assessments on materials and additives and potential leachables and degradation products.
The CER demonstrates that the device achieves its purpose without exposing users and patients to further risks.
The Clinical Expert Report is required for all medical devices in Europe and must be submitted to the Notified Body chosen as an attachment to the technical documentation for the CE mark.
The technical documentation represents an essential step to obtain the CE mark for the Device, which is a mandatory requirement to sell or distribute a medical device within the European Community.
