Easy Testing

Easier Compliance

ECM Notified Body 1282

In business there’s a saying: Time is money.

For manufacturers of Medical Devices, it makes business sense to test their products: failure of your medical device can be costly to your bottom line and damaging to your company’s reputation. From a regulatory perspective, medical device testing helps to ensure products are released to the market the right way, reducing risk. When it comes to medical device development, early testing can help to detect critical bugs and vulnerabilities, especially in relation to the safety of the device.

Undergoing tests is a critical step in the process of transforming an innovative design into a reliable and marketable product.

ECM Testing Lab has ISO 17025 accreditation and is recognized as NCB and CBTL for the CB Scheme.

ECM Testing Lab Service combines of testing expertise with a support network of nationally accredited laboratories and facilities. Deep knowledge of the requirements and proven medical device test engineers are the key to ensuring smooth testing for your medical device. This is the value we bring as a trusted Medical Device Testing Lab partner to manufacturers, from startups to Fortune 500 organizations.

Approaching the 60601 standard

To access the EU market, your Electric Medical Device must comply to the CE marking. Understanding and satisfying the requirements of EN 60601 is fundamental for all manufacturers of Medical Electrical Equipment.

IEC 60601-1-2 for Medical Electrical Devices

IEC 60601-1-2 is the primary EMC standard for Electric Medical Devices and systems.

From pre-compliance to full-compliance testing, EMC Labs are equipped to evaluate your medical device against requirements within the EMC Directive, including IEC 60601-1-2 and IEC 60601-2 for particular standards.

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Electro-static Discharge (ESD) Testing

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EMC
Pre-compliance Scans

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Radiated
Emissions
Testing

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Radiated
Immunity Testing & More

IEC 60601-1 3rd Edition Standard

IEC 60601 collects a wide range of international standards on the safety and essential performance of Electric Medical Devices and equipment.

The testing of safety and basic performance of Electric Medical Devices are regulated by the IEC 60601-1 to avoid failures (electric, mechanical, functional) that can bring unacceptable risks to patients and operators. In many countries IEC 60601-1:2005 is a pre-requisite for the commercialization of Electric Medical Devices.

Make a smooth transition to IEC 60601-1:2005+A1:2012 (latest amendment) with reduced cost and complexity by taking advantage of ECM Testing Labs.

Compared to previous edition, the IEC 60601-1:2005 3rd Edition consists of close to 700 entirely new or more stringent requirements, with risk management becoming a crucial requirement.

Why choose ECM for testing
compliance to EN 60601?

  • ECM has a deep knowledge and experience in testing to EN 60601-1 and 60601-1-2

 

  • The laboratories in our network are members of the CB Scheme which ensures global recognition of test reports and certificates
  • We can provide pre-test inspection and assistance in developing test plans, including risk management expectations

 

  • Our regulatory experts are product specialists for a wide range of devices and with many years of experience in testing and design.

Let's talk about

ECM America -Unit 506 – 1110 Brickell Avenue 33131
Miami, Fl

(833) 326-2378info@ecmmedicaldevices.com

ECM HQ - Via Ca' Bella, 243, 40050
Valsamoggia (BO)

+39 051 670 5141info@entecerma.it