Medical sector
Services and expertise dedicated to the compliance and marketing of your medical devices (MD) and in-vitro devices (IVDD)
The Emitech Group supports you at every stage of the compliance process for your medical devices (MD) and diagnostic equipment, right up to their market launch, with CE marking in Europe and its international equivalents.
Our accredited laboratories and regulatory expertise provide you with a tailor-made response to the requirements of European regulations (MDR/IVDR), as well as international standards applicable to your connected, electronic or software-embedded devices.
Our scope of application
Applicable standards and specifications
- EN 60601-1 / EN 60601-1-2: safety and electromagnetic compatibility of electromedical devices
- IEC 62304: medical software life cycle
- ISO 14971: risk management
- IEC 61010: safety of laboratory equipment
Talk to our experts dedicated to the medical sector
Our expertise in medical device compliance
EMC and radio testing
- Measurement of radiated and conducted emissions in accordance with the requirements of standard EN 60601-1-2
- Assessment of electromagnetic immunity in representative environments
- Radio testing (Bluetooth, Wi-Fi, RFID) in line with the requirements of the RED Directive (2014/53/EU), in addition to CE marking under the MDR/IVDR
- Carrying out test campaigns in hospital environments (coexisting equipment, interference, electromagnetic disturbance, etc.)
Electrical safety tests
- Assessment in accordance with EN 60601-1 (DM) and EN 61010 (DM DIV)
- Tests on power sources, patient and operator protections
- Measurement of leakage currents, insulation, earth continuity and protective devices
- Voluntary application of the principles of the Low Voltage Directive (2014/35/EU), where relevant for multi-regulated products
Climatic, mechanical and reliability tests
We test the robustness and reliability of your devices under extreme or realistic
extreme or realistic environmental conditions:
- Mechanical testing: vibration, shock, dropping, fatigue, etc
- Climatic testing: humidity, extreme temperatures, thermal cycles, etc
- HALT / HASS methods for early failure detection
- Simulation of conditions of transport, storage and critical use, with a view to qualifying the product throughout its life cycle
CE marking, MDR / IVDR compliance and additional directives
- Compilation and review of regulatory technical documentation (MDR 2017/745 or IVDR 2017/746)
- Application of harmonised and specific standards.
- Risk analysis and review of safety and performance requirements
- Assistance in identifying the requirements applicable to combined devices (MD + radio, MD + software, etc.)
- Conformity testing for RED and EMC directives, if applicable
- Preparation for assessment by a notified body, if necessary
International certification - CB Scheme / CB certificates
- Co-ordination of test campaigns in accordance with international standards (e.g. IEC 60601, IEC 61010, etc.)
- Preparation of files for the issue of CB certificates
- Optimisation of access to more than 50 countries that are members of the CB scheme
- Harmonisation of technical requirements to limit duplication of testing between regions
Training
dedicated training courses:
- Sessions dedicated to EMC and safety standards for medical devices
- Specialised modules on CE marking, RED and BT directives
- Raising awareness of MDR requirements and risk management
Related Services
Besoins
Retrouvez ici une sélection de contenus complémentaires qui approfondissent les thématiques en lien avec cette page : contextes réglementaires, articles techniques, ou encore expertises spécifiques. Ces contenus vous apportent un éclairage supplémentaire pour mieux comprendre les enjeux et les solutions disponibles.
Full support to get you to market
We guide you from design to regulatory compliance, for all types of medical devices, including those with radio, software or monitoring functions - in Europe (CE marking) and internationally.
