To ensure the safety, performance, and regulatory compliance of your active implantable medical devices (AIMDs), LNE supports you from the design stage through to market launch, offering a comprehensive range of services. As a leading organisation in the medical sector, we provide technical and regulatory expertise, particularly in relation to the ISO 14708 series and EN 45502-1, helping you streamline your development and regulatory processes.
As manufacturers of active implantable medical devices, you face specific challenges related to regulatory compliance and continuous technological innovation. LNE supports you from the design stage through to market launch, offering a wide range of services covering your safety and performance requirements. We also assist you in addressing the biocompatibility, connectivity, and cybersecurity challenges associated with your medical devices.
Testing of active implantable medical devices
Safety and performance: electrical safety, EMC, validation of sterile packaging
- Electrical safety, to assess protection against electrical and related safety hazards and to support the demonstration of basic safety,
- Electromagnetic compatibility (EMC), to ensure that products function correctly in their electromagnetic environment and do not interfere with it,
- Mechanical testing: tensile, compression, vibration, torsion, etc.,
- Bespoke testing to reproduce, under laboratory conditions, the stresses encountered during device use,
- Sterile packaging validation, including transport simulation (to assess the behaviour of the device and its packaging when subjected to various stresses associated with their distribution cycle), accelerated ageing, and sterile barrier performance testing (ISO 11607).
Connectivity: radio, cybersecurity, AI
- Radio frequency (RF), to assess the performance and compliance of connected medical devices using technologies such as Wi-Fi, Bluetooth, RFID, 2G, 3G, 4G and LoRa, in accordance with applicable standards,
- Cybersecurity, to ensure the management of cybersecurity risks by minimising vulnerabilities,
- Artificial Intelligence, to meet the reliability and compliance requirements set out in the AI Act.
Biocompatibility and reliability: ISO 10993, ageing, particles
- Quantitative and qualitative assessment of unintended particle load, to demonstrate the overall biological safety of AIMDs: characterisation of particles (solid, liquid, or gaseous) likely to be released by the device upon contact with the human body. These assessments may support the biological evaluation with chemical and material characterisation of medical devices, in accordance with the ISO 10993 series, including:
- ISO 10993-18: chemical characterisation of materials,
- ISO 10993-19: physicochemical, morphological, and topographical characterisation of materials.
- Particle release tests available at LNE: quantification and characterisation of particles emitted by AIMDs, including analysis of particle size distribution and particle composition. These tests utilise advanced analytical techniques such as aerosol generation systems, Aerodynamic Particle Sizer (APS), SEM-EDX, ICP-MS, µFTIR, etc.,
- Photobiological and optical safety tests: characterisation of optical radiation sources (incoherent and laser), medical lighting systems, characterisation of instruments, etc.
Certifications for active implantable medical devices
- CB Scheme certification for the external, non-implantable part: facilitates access to international markets for electrical and electronic products and equipment; helps to optimise costs and lead times, in particular by enabling a single test programme (safety, EMC, cybersecurity) to be carried out instead of one for each target country,
- CE marking: compliance with the Medical Devices Regulation (MDR) through the notified body GMED.
Why choose LNE?
- A multidisciplinary expert recognised nationally and internationally in the medical and healthcare sector (testing, certification, metrology, technical and regulatory support, etc.), supported by its subsidiary GMED, a notified body and a major player in the sector,
- A single site, accredited by Cofrac*, to carry out all the tests required for conformity assessment,
- Tailored support, from design through to regulatory validation,
- Tests carried out in accordance with the requirements of the Medical Devices Regulation (EU Regulation 2017/745) and recognised expertise in the ISO 14708 series and EN 45502.
*List of accreditations, sites and scopes available at cofrac.fr
Regulations
- ISO 14708 series / EN 45502-1: Active implantable medical devices
- IEC 60601-1 series: Medical electrical equipment
- IEC 60601-1-2: Electromagnetic compatibility
- ISO 10993 series: Biological evaluation of medical devices
- ISO 11607 series: Packaging for terminally sterilized medical devices
- MDR: Regulation EU 2017/745
For all your other medical devices, we offer tailored testing solutions designed to meet your specific needs.
