With many years of experience within the health and medical device marketplace, Bureau Veritas Electrical is your partner of choice for medical device compliance assistance.
Shorten time to market access for your products
We provide you with solutions and advices answering your specific needs all along the industrial process
Assess your product's characteristics and compliance
As an independent testing laboratory, we assess the conformity of electromedical devices to the requirements of European and international standards and regulations, as well as technical specifications
Products Covered
medical devices for diagnostic, treatment, therapy and supervision use
Assess the conformity of your products - Needs for testing services
We benefit from multidisciplinary skills and a wide range of testing and measuring equipment covering:
We analyze the market access requirements for your health and medical equipment and can prepare a complete technical file in order to verify and assess the quality and conformity of your products and the associated manufacturing controls. This can be against many legislative barriers to trade including CE marking (Safety, EMC, RF), FCC requirements for North America and Environmental legislation such as RoHS/WEEE Directives, Energy Using Products Directive, REACH regulations and much more.
Checking your product compliance to standards and regulations, in the shortest period of time
Our advice is always totally impartial and fully confidential. Our services are provided to take into account your particular time constraints.
Obtaining conformity marks for all markets
Bureau Veritas Electrical is an accredited organisation in many countries worldwide allowing us to issue certificates and marks of conformity recognised throughout the world, as proof of the reliability of your consumer electronics products.
Location Bureau Veritas was established in 1828 and has in excess of 23,000 employees located in 140 countries. We have access to 5,000 employees in 40 countries worldwide within the Bureau Veritas Consumer Products Service group with electrical focussed office and laboratory locations in USA, France, Germany, UK, China, Hong Kong and Taiwan
Knowledge - Access to our dedicated information resource center tracking the electrical legislative developments and advising on its impact
Capability - Access to CB Scheme (access to 70 countries with one test) certification as well as access to our comprehensive accredited EMC, Safety and Environmental Test facilities in all three continents
Knowledge - Future legislation consultants who can advise on the impact of RoHS, REACH, EuP, China RoHS, etc… and other legislation as it develops
Price – With offices and facilities all over the world, we can offer incredibly competitive rates for our services
Bureau Veritas Electrical Services
Testing
LCIE is COFRAC Accredited (testing part) to perform testing on electromedical devices
Safety testing
Functional and performance testing
Assessment of the reaction in environments (temperature, mechanical, protection index,
Electromagnetic compatibility
Assessment of testing performed in the manufacturers’ laboratories
Certification
LCIE is Notified and Competent Body for the application of the European directives; Low Voltage, EMC, R&TTE
We issue certificates of compliance
NF Mark
LCIE is designated by AFNOR Certification to deliver the NF Medical Mark for lighting equipment for surgery blocks
CB certificates and testing reports
European conformity marks : CCA-EMC, simplified access to various national marks through the CCA agreement (Cenelec Certification Agreement)
Foreign marks: UL and CSA-US marks for the USA, CSA and C-UL for Canada, GOST R (NCB GOST Re) for Russia
In the framework of bilateral agreements, LCIE perfroms testing programs according to the requirements of applicable standards and plant inspections. LCIE also handles relationships with foreign certification bodies.
Consulting
Identification of applicable standards and regulations
Assistance in drawing up specifications
Assistance in building the conformance file
Numerical simulation
Dependability: securization of installations, production audits (technical, quality)
Production control, failure analysis
Functional safety, identification of default risks of equipment and softwares
Numerical and reliability calculation
Market analysis, technical comparative studies
Assistance for exports, identification of applicable standards and regulations, handling relationships with foreign certification bodies
Assistance in the settlement of quality procedures
Assistance for methodology
Prevention of hospital risks
Guidance in purchasing medical devices
Verification of dental, medical or industrial radiology chambers
Assistance in the maintenance of power transformers
Technical controls on medical devices according to the requirements of applicable standards, and upon request of health establishments or State entities
Technical expertise performed upon request from industrial players
Assessment of the modifications performed on medical devices
Consumer Electronics 
Non Electrical CPS