Medical Devices (MD), Electromedical Devices, and In Vitro Diagnostic Medical Devices (IVDMD)

LNE offers a wide range of testing methods to evaluate the performance and safety of medical devices. These tests are based either on standard tests or custom tests (such as risk analysis) to evaluate performances or risks not covered by a standard.

 Note: the test reports issued at the end of these services contribute, among other things, to obtaining the CE marking or any other international regulation (e.g., FDA).

• Mechanical characterisation: These tests aim to characterise the mechanical resistance of traction, compression, or torsion of products to ensure they will be compliant and perform well during use.
• Vibrations, shock and constant acceleration: these tests make it possible to evaluate the mechanical behavior of products under normal or severe conditions of use. These tests include transport simulation.
• Climatic conditioning: climatic tests test the robustness and proper functioning of the product in harsh environments, with variations in temperature and humidity or pressure. Climatic conditioning is also used to carry out accelerated ageing tests to assess the stability of the product instead of waiting for its actual ageing on the shelf.
• Tailor-made tests: these tests are carried out to assess the control of a risk or as part of the demonstration of the performance of medical devices. With the help of its design office and its experts, LNE sets up tests according to the customer's specifications.
• Packaging performance: sterile packaging (tests according to ISO 11607-1 sterile barrier), non-sterile and ;transport
• Biocompatibility tests: chemical analyses, material characterization, leaching, nano, ethylene oxide VOC residues.

Good to know: for implantable MDs we carry out nanoparticle characterization (in french only)

GMED, a subsidiary of LNE, is a notified body designated under Regulations (EU) 2017/745 and (EU) 2017/746 on medical devices and in vitro diagnostic medical devices. As such, GMED is authorised to issue CE marking certificates.

• CE marking

LNE also issues NF marks for the following products:

• NF Medical beds, lifts and mattresses for medical use
• NF Packaging of healthcare waste (DASRI)
• NF Microbiological Safety Station
• And its own brand for protective masks (in french only)

• Technical and regulatory evaluation: an expert will help you decipher the standards applicable to your product, evaluate their implementation with you, evaluate the discrepancies and answer your questions to help you understand and apply the regulations.
• Training: European and international regulations, quality management system, special processes, risk management, testing, our training in the field of MD and DM IVD allows you to train yourself in the state of the regulatory and technical art.
  They are available in inter-company, intra, e-learning, etc.
  Consult our training catalog (in french only)

 LNE offers a wide range of test methods to evaluate the performance and safety of active medical devices in vitro diagnostic MDs. They are based either on normative tests or on custom tests to assess performance or risks that would not be covered by a standard.

Note: The test reports issued at the end of these services contribute, among other things, to obtaining the CE Marking or to obtaining a CB Scheme certification, to target international marketing for example.

• Electrical safety tests: these tests ensure the basic safety of products and users with regard to electrical, mechanical, thermal and fire resistance risks.
• Electromagnetic compatibility tests (EMC): these tests ensure that products function properly in their electromagnetic environment, and that they do not disturb their environment.
• Radio frequency tests: these tests demonstrate the compliance of connected medical devices (WiFi, Bluetooth, RFID, 2G, 3G, 4G, etc.) in terms of communication, according to the applicable standards.
• Safety and performance of electro-medical devices according to IEC 60601
• Mechanical characterization: these tests aim to characterize the mechanical tensile, compressive, or torsional strength of products in order to ensure that they will withstand their use.
• Vibrations, shock and constant acceleration: these tests make it possible to evaluate the mechanical behavior of products under normal or severe conditions of use (e.g. DMIA, 500g acceleration tests). These tests include transport simulation.
• Climatic conditioning: climatic tests test the robustness and proper functioning of the product in harsh environments, with variations in temperature and humidity or pressure. Climatic conditioning is also used to carry out accelerated ageing tests to assess the stability of the product instead of waiting for its actual ageing on the shelf.
• Tailor-made tests: these tests are carried out to assess the control of a risk or as part of the demonstration of the performance of medical devices. With the help of its design office and its experts, LNE sets up tests according to the customer's specifications.
• Photobiological and optical risks: characterization of optical radiation sources (incoherent and laser), medical lighting systems, instrument characterization, etc.
• Characterization of acoustic properties (in french only): hearing aids, audiometers, alarms of medical devices, etc.
• Artificial intelligence: technical evaluation of embedded AI in medical devices (performance, influencing factors, robustness, resilience, etc.) to meet the needs of reliability and compliance..
• Cybersecurity: cybersecurity assessment, threat model, cyber assessment, penetration tests on embedded products, to ensure their security and robustness, particularly in the face of cyber attacks.
• Packaging performance: sterile packaging (tests according to ISO 11607-1 sterile barrier), non-sterile and transport packaging

Good to know: for implantable MDs we carry out nanoparticle characterization (in french only)

• CE marking: GMED, a subsidiary of LNE, is a notified body designated under Regulations (EU) 2017/745 and (EU) 2017/746 on medical devices and in vitro diagnostic medical devices. As such, GMED is authorised to issue CE marking certificates.
• CB scheme: facilitates access for electrical and electronic products and equipment to international markets, optimizes costs and deadlines, in particular thanks to the possibility of carrying out only one test campaign (safety, EMC, cyber) instead of one per targeted country.
• Artificial Intelligence: certification of the design, development, evaluation and maintenance processes of all types of AI functionalities with machine learning.
• ISO 42001 certification, aimed at establishing, implementing, maintaining and continuously improving an AI management system.

European and international regulations, quality management systems, special processes, risk management, testing, our training in the field of MD and MD IVD allows you to train yourself in the state of the regulatory and technical art.
They are available in inter-company, intra, e-learning, etc.
Consult our training program(in french only)