IEC 60601 Medical Device Safety Test

Medical Tests

IEC 60601 Medical Device Safety Test

Used in various countries of the world, IEC 60601 helps ensure the safety and effectiveness of electrical and electronic medical devices. We use our product qualification and EMC expertise to ensure that your medical devices and products meet IEC 60601 standards and are ready to be exported to global markets.

IEC 60601 Medical Device Safety Test

Combining industry experience with state-of-the-art laboratory testing facilities, EUROLAB offers a complete suite of medical device testing and certification services to ensure that you meet the required IEC 60601 product safety requirements recognized worldwide. Our services range from product design and prototype evaluation to formal compliance testing, certification and ongoing standards and legal advice.

EUROLAB can assist you at any stage of your medical device project by offering the best certification option for your product, markets and business.

Some of our IEC 60601 Medical Safety Test services:

  • Training support for IEC 60601 - home or on-site training at the customer site
  • Gap evaluation according to 60601 series, IEC62304, IEC62366, ISO14971 and other standards
  • Early Stage Qualification (ESQ®) services for compliance with IEC 60601
  • Test reports and certificates for CB Scheme
  • Risk management and integrated quality system (ISO 13485 and / or ISO 14971) evaluations
  • IECEE CB accreditation for international CB certification scheme
  • Software and usability assessments to support various IEC 60601 substances
  • EMC testing and evaluations according to IEC 60601-1-2
  • Home health assessments to support IEC 60601-1-11
  • CE Mark of Class I, IIa, IIb and III devices

Design and safety tests of electrical and electronic medical devices

Before new devices are categorized as 'safe' for use in the medical environment and put on the market, it is necessary to determine whether a device can operate safely and effectively without causing damage or electromagnetic disturbances in the appropriate working environment.

Support early in the product development lifecycle

Participated experts from EUROLAB can help you determine which standards to apply for your device, evaluate your design features for suitability, and offer an effective risk management program from the beginning of the project. We also provide new companies with additional entry and guidance in the early stages of medical device development and design, ensuring that entry barriers are addressed as early as possible and a robust regulatory and market-opening strategy is developed.

Risk assessment and file management

We offer unbiased third-party support in all areas of product development, from design consultancy, full product safety testing and completion of the Declaration of Conformity (DoC) to compilation and review of Technical Files. With top-notch expertise in electrical and electronic medical device testing, our experts provide you with consultancy guidance and feedback throughout the product development process, so you can be sure to launch your product.

Achieving compliance with ISO 60601, a crucial requirement for IEC 14971

When complying with IEC 60601 standards, risk management must be applied to medical devices. Compatibility is not possible without this documentation; we can assist you with this and provide support and guidance on ISO 14971 risk management, including:

  • Bespoke and one-to-one training
  • Documentation and procedure review
  • Production of required documents
  • Gap Analysis, improvement and mitigation

CE Marking of electrical medical devices

EUROLAB's specialists guide you through every step of the CE Marking process for medical devices that provide successful and efficient product launches.

CB Scheme certification and CE Mark for IEC 60601

The IECEE CB certification meets most CE Marking requirements for medical and electronic equipment safety in Europe and means that you only have to test your product once in one place.

With years of experience, EUROLAB is the leading provider of IECEE CB certificates covering a wide range of certifications, including the IEC 60601 series for medical equipment.

Global approvals for access to the international market

Our security experts understand the safety testing challenges of medical products for global exports and assist manufacturers with 3rd party tests in district representation, product translation and more to achieve higher speeds in the market for successful product launches.

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