Medical and Electro-medical Devices
Choosing us as a partner will reduce costs and time to market. Our test reports and certificates are recognized and accepted as meeting the requirements for certification at national level.
Optimize the certification process
Test reports can be obtained which meet international standards on safety, EMC, telecom and the environment, demonstrating compliance with national requirements.
We can evaluate your EN/ISO 14971 risk analyses, your EN/ISO 62366 or 60601-1-6 usability assessment and your IEC 62304 medical software validation.
The tests performed in the Test’Ing laboratory are designed to evaluate your medical and electro-medical devices, ascertaining proper functioning and safety in terms of electromagnetic compatibility, and thus determine the interference that may arise in other electro-medical equipment present in the same environment.
Our tests also determine the potential electrical risks to both patients and operators, i.e. direct or indirect contacts with live parts, burns, or explosion and/or fire due to the use of flammable products.
Our experts will manage your projects and follow their delivery. Thanks to the available medical equipment testing facilities.
- Medical Device Directive 93/42/EC and 2007/47/EC and EU regulation 2017/745
- In Vitro Diagnostic Medical Device Directive 98/79/EC and 2007/47/EC
- Active Implantable Medical Device Directive 90/385/EEC
- Electromagnetic compatibility directive 2014/30/EU
- Low Voltage Directive 2014/35/EU
- Radio Equipment Directive 2014/53/EU
- CEI EN 60601-1 general requirements
- CEI EN 60601-2-XX specific requirements
- CEI EN 62471
- CEI EN 55011
- CEI EN 60601-1-2