Medical Devices Testing & Compliance Solutions

Navigating the complex landscape of medical electrical device compliance and regulatory approval is critical for manufacturers aiming to bring innovative medical electronics safely to market. At Bureau Veritas, we specialize in comprehensive medical electronics testing to ensure your products meet essential safety, performance, and market access requirements globally.

Our services cover a broad range of medical electrical devices, including patient monitors, ventilators, ophthalmic and dental equipment, infusion pumps, and in-vitro diagnostic (IVD) devices. We conduct thorough evaluations of electrical safety, electromagnetic compatibility, wireless connectivity, and cyber security — all essential components of effective medical electronics testing.

Our globally accredited laboratories provide certification under CB Scheme, ILAC, and NRTL programs to support your product's regulatory approval across major markets such as the US, Canada, Europe, and beyond. We offer expert guidance throughout the product lifecycle, from initial design and risk assessment to testing, certification, and final market entry.

Your Global Medical ELECTRICAL Device Partner

Key Testing and Compliance Areas Include:

· Electromagnetic compatibility (IEC 60601-1-2, CISPR 25, RTCA DO-160 Sections 21.4, 21.5)
· Wireless co-existence per ANSI C63.27
· Immunity testing for exposure to RFID per AIM 7351731
· Wireless connectivity (2G/3G/4G-LTE, WiFi, Bluetooth, NFC, RFID, Zigbee, Zwave)
· Electrical basic safety and essential performance (60601-1)
· Alarms (60601-1-8)
· Home Healthcare (60601-1-11)
· Emergency Medical Services (60601-1-12)
· Laser testing and evaluations (60825-1, 60825-2, 21 CFR 1040.10, 21 CFR 1040.11, EN 50689)
· Eco-environment (hazardous substances analysis, lifecycle analysis)
· Biocompatibility (ISO 10993 series)
· Cybersecurity (ANSI/UL 2900, IEC 62443, IEC 60601-4-5, IEC 81001-5-1, AAMI TIR 57)
· Environmental simulation
· Reliability testing (corrosion, UV exposure, ingress protection, shock and vibration)
· Mechanical and climatic
· Global Market Access (GMA) for Wireless Devices
· NRTL Certification (for US and Canada)

Bringing a medical device to market involves stringent regulatory hurdles such as MDR in Europe or FDA clearance in the US. Failure to meet these standards can delay or block product launch, causing significant financial risk. Bureau Veritas supports you in managing these challenges efficiently, reducing risk through expert compliance consulting and rigorous product testing.

REGIONAL HIGHLIGHT: MEDICAL Electrical Device Center of Excellence - Littleton, MA, USA

Your partners through the life of your product

The Bureau Veritas (Littleton, MA, USA) Innovation Center is a comprehensive testing and certification facility that supports clients in the Electrical, Medical, and Renewable Energy industries. This state-of-the-art laboratory offers Safety, EMC, Wireless, Radio, and Environmental, testing services to help manufacturers navigate complex national and international standards and regulations. The 60,000 sq. ft. test center is equipped with advanced technology to provide testing and certification for a wide range of electronic devices, including wireless technology, telecommunications equipment, medical devices, and consumer electronics. Located in New England, 40 minutes outside of Boston, the Littleton facility serves clients across the United States and globally, helping them confirm their products meet necessary safety and performance standards for various markets. We are a third-party accredited Nationally Recognized Test Lab (NRTL), IECEE CB scheme test lab, and U.S. FDA ASCA approved testing laboratory.

Scope of Accreditations:

A2LA
IECEE's CB Scheme
OSHA (NRTL) Program
Standards Council of Canada (SCC)
US FDA's ASCA Program

Our MEDTECH Solution Highlights

Biocompatibility

EVALUTATING THE RISK OF MEDICAL DEVICES

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Process – ISO 10993 Screening Analysis
The combination of our state-of-the-art equipment and a highly skilled team enables Bureau Veritas to provide identification and qualification for an unexpectedly high number of compounds.
Download our service sheet

Visit our Biocompatibility page
Insourcing

BUREAU VERITAS EXPERTISE ON-SITE, AT YOUR LOCATION

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Through our comprehensive approach to staff management, we take care of the complexities, enabling your scientific team to fully engage in their innovative work. Our expertise in scientific staffing allows your experts to dedicate their time and skills to advancing scientific knowledge.
Download our Insourcing service sheet
MDSAP

NCC SIMPLIFIES THE CERTIFICATION OF MEDICAL PRODUCTS!

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The medical device single audit program (mdsap) is a system that enables a single audit of a medical device manufacturer to satisfy the requirements of multiple regulatory authorities.
Download our MDSAP service sheet
Electro Medical Services

VERIFYING YOU ARE COMPLIANT WITH GLOBAL REGULATIONS

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As a leading testing and certification company, Bureau Veritas offers comprehensive services for electro medical devices to facilitate fast and efficient market access and validate compliance with global regulations.
Download our Electro Medical Service Sheet
Eco-Design and LCA

CENTER OF EXCELLENCE IN ENVIRONMENTAL PRODUCT MANAGEMENT

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Bureau Veritas has had an LCA and Eco-design expertise center for more than 25 years. CODDE is a department of Bureau Veritas, a leading testing laboratory and certification body.
Download our service sheet

Link to our Eco-design page

QUICK LINKS TO OUR SERVICES

· Pre-Compliance Testing/Evaluation: Early-stage evaluation to identify potential product issues and improve design before full certification testing.

· Certification (CB Scheme): International certification ensuring your medical device meets global safety and performance standards through a recognized mutual acceptance system.

· Certification (NRTL Program): Certification for electrical safety compliance to access the US and Canadian markets under recognized Nationally Recognized Testing Laboratory programs.

· U.S. FDA ASCA Program: FDA-recognized accreditation program that streamlines medical device testing and inspection processes for faster market entry.

· Electromagnetic Compatibility (EMC): Testing to ensure medical devices operate safely and effectively without causing or being affected by electromagnetic interference.

· Product Safety Testing: Comprehensive evaluation of electrical, mechanical, and environmental risks to verify basic safety and essential performance of devices.

· Environmental Performance and Reliability: Assessment of device durability under varied environmental conditions such as temperature, humidity, and mechanical stress.

· Cybersecurity: Evaluation of medical device security to protect data integrity, privacy, and resist cyber threats in accordance with industry standards.

· Global Market Access: Support services ensuring your medical device meets regulatory requirements worldwide for smooth entry into multiple markets.

MEDTECH Service Sheet

Download our MEDTECH service sheet

CONNECT WITH US TODAY

Our dedicated MedTech solutions team supports manufacturers at every stage—concept, production, certification, and global distribution—ensuring your medical electronics achieve trusted certification and regulatory approval for successful market penetration worldwide.

Contact us to learn how Bureau Veritas can accelerate your medical device compliance journey with reliable, end-to-end testing and certification solutions.

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