Medical devices (MD) – Electro-medical devices (EMD) – Implantable medical devices (IMD) – Active implantable medical devices (AIMD) – In vitro diagnostic medical devices (IVDMD)
Guarantee the safety of practitioners, users and patients for all your medical devices, all the while rising up to challenges of competitiveness, innovation / R&D and conformity.
Services offered by LNE
Competitiveness: a unique and specialised contact for all your certification applications
Access to worldwide markets:
- Europe : CE Marking for all classes of medical devices (MD) (directive 93/42/EEC) and all paths to regulatory certification.
- France : NF Mark for toothpaste, condoms, lubricating gels, medical beds, eschar prevention devices, operating tables, patient lifts…
The CB Scheme programme enables the recognition of electrical safety and electromagnetic compatibility tests in more than 50 countries
LNE is recognised by the IECEE to issue conformity certificates in accordance with about thirty standards..
- Countries that are members of the CB Scheme programme: CB Scheme Certification. It helps market electro-medical devices worldwide by enabling the recognition of electrical safety and electromagnetic compatibility tests in more than 50 countries participating in the programme (Argentina, Australia, Brazil, Canada, India, Japan, the EU, Russia, the USA...).
- Brazil: INMETRO Certification for your electro-medical devices. Apart from Brazil, LNE is one of the only organisations to issue this certificate, which gives access to the Brazilian market.
- North America and Canada: Our NRTL partnership gives access to these markets for your electro-medical devices.
- Taiwan : ISO 13485 Technical Cooperation Programme (TCP)
- Canada : ISO 13485 SCECIM/CMDCAS Programme
- The USA : SCECIM/CMDCAS Programme (Inspection by Accredited Persons) – 21 CFR Part 820
- Australia and New Zealand : Mutual Recognition Agreements (ARM)
- Japan : Mutual Recognition Agreements. LNE is a JPAL-certified auditor
Inspections for American, Canadian, New Zealand certification
Customized comparative tests
Innovation and r&d: personalized accompaniment
Technical assistance, technical and regulatory assistance and information before product design
Are you developing an innovative product?
If you have questions regarding reference documents and standards that apply to your product, our teams are here to give you advice, develop and implement specific and adapted testing protocols.
For any contact: firstname.lastname@example.org
This service can cover:
- A presentation of the regulatory context applicable to MD and of harmonised standards used as tools for presumption of conformity
- A presentation of European guides and recommendations (MEDDEV Guidelines, Guidelines Global Harmonization Task Force (GHTF)).
- Discussions on how to show clinical evidence according to the degree of innovation of the MD.
- Explanations about the responsibilities, roles and missions of manufacturers/agents, importers, distributors…
Drafting of specifications for prototypes, validation of performance, organisation of monitoring in production
Customized development tests:
- Development of reference benches, measurement and testing methods for innovative equipment and materials
Conformity: a multidisciplinary expertise
Our testing methods rely on the harmonised standards associated with directives 93/42/EEC and 90/385/EEC.
- In accordance with European directives or foreign regulations (e.g.: CE marking, ISTA, ASTM, ISO, IEC, Eurolab, CB Scheme, NRTL)
- Verification of functional requirements related to the performance and safety of the device
- Electrical safety tests (ES)
- Electromagnetic compatibility tests (EMC)
- Static and dynamic mechanical tests (fatigue, shock)
- Mechanical stress testing of packaging (falls, shocks, vibrations, acceleration…) – Transport Simulation Test (ISTA)
- Climatic tests and ageing resistance
- Physical and chemical tests
- Chemical analyses (for example, internal breast implants: salting out of the shell, release of silicone)
- Fire tests
- Acoustics tests
- Expertise, Technical Assistance and Technical and Regulatory Assistance (TRA)
Calibration and measurements in laboratory and/or on site:
- Measuring instruments calibration
- • Verifications in accordance with standards or other reference documents in force (GMP, specifications from your customers…):
- - Air quality measurements (industrial air and compressed air, clean rooms, dust, particles, oil, humidity, pollutants…)
- - Climatic and temperature chambers
- Training and accompaniment
Assistance with the management of measuring instruments installed basis
- Determination of causes of failures, rupture, degradation
- • LNE’s internal or joint training programmes enable manufacturers and health establishments to control the specificities of standards and regulations of French and international markets. Courses are aimed at quality managers, auditors, engineers and industry and health establishments technicians.
- • Feel free to consult our training course catalogue and subscribe online.
Hill-Rom has chosen LNE for CB Scheme testing of their medical beds
As an internationally established specialist in hospital equipment, Hill-Rom must place on the market products that comply with regulations applicable in each country where these products are marketed. As for their electric medical beds, CB Scheme certification turned out to be the most effective solution to optimise costs and development time…
[Read testimonial from Hill-Rom] (in French)