Meet ECM at Arab Health

From 28 to 31 January our Sales Manager for Medical Devices Antonio Balassone will be in Dubai to attend Arab Health, the largest healthcare exhibition of the MENA region. With more than 4.000 exhibitors coming from 66 different countries and about 85.000 professionals attending, Arab Health is the leading medical trade fair of the Middle East. For […]

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We are Accepting Applications for CE and ISO Certification!!

To all medical device professionals and manufacturers: We want to inform you that we are still accepting applications for CE and ISO certification!! With the new MDR quickly approaching, Notified Bodies are facing many challenges, and it’s not easy to respond to all the requests from the market. Our experienced staff has already submitted the […]

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Advancement Towards Designation

EU MDR

  Advancement Towards Designation – ECM Submits MDR Application ECM is proud to announce another important step taken towards the new MDR. ECM has submitted to the competent authorities the MDR application in accordance to the European Medical Device Regulation 2017/745. And, optimism for a joint assessment is underway. January 2019 continues the transitioning roadmap […]

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ISO 13485 & MDSAP Deadlines are Fast Approaching (And You Need a Notified Body)

In less than four months, come March 2019, the transitional period for medical device companies to comply with the new ISO 13485:2016 standard will end. With so many changes that must be implemented to comply with this rigorous standard, companies should not wait any longer to begin the transition. Lack of preparation could lead to […]

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Transitioning Like a Pro to the EU MDR

Transitioning Like a Pro to the EU MDR Transitioning as seamlessly as possible to the new MDR involves implementation of three concepts: preparing for the transition without delay, understanding major points of change in the MDR and effectively adhering to compliance regulations to avoid disruptions. By shifting regulatory focus from the pre-approval stages covered extensively […]

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ISO 13485:2016 – Less than 6 Months for Transition

Next March 2019, the transitional period for medical device companies to comply the new ISO 13485 standard will end. What are the differences between the EN ISO 13485:2012 and the ISO 13485:2016 standards? What are the new requirements? How to comply? The driver behind the new version of the ISO 13485 standard is the promotion […]

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ECM Performs EMC Testing

Medical devices are required to comply to the EN 60601-1-2:2015 Standard. Mirko Masotti, ECM’s chief engineering officer, conducts Electromagnetic Compatibility (EMC) tests on medical devices in accordance to the EN 60601-1-2:2015 Standard. Specifically, the diathermy device has been tested to ESD tests (electrostatic discharges) according to standard IEC 61000-4-2 and submitted to a particular debugging […]

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ECM will exhibit at RAPS – Regulatory Convergence in Vancouver, October 1-4 2018

From 1st to 4th October you will find us at RAPS Regulatory Convergence, at the Vancouver Convention Centre, Vancouver, BC – the leading annual international event for professionals in the regulatory affairs of medical devices, in vitro, pharmaceuticals and related technologies. Experts from notified bodies, consulting companies and the medical industry from all over the […]

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