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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ISO 9001:2015 The New International Quality Standard Comes into Force on September 15

  The three-year transitional period granted to re-certify or upgrade, through an accredited certification body, from ISO 9001:2008 to the new ISO 9001:2015 Quality Management System ends on September 15, 2018. As the world’s leading quality management standard, ISO 9001 can apply to any organization and has over one million certificates issued in more than […]

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ISO 13485 Quality Management System Certification for Medical Devices

The ISO 13485 standard “Medical devices – Quality Management Systems – Requirements for regulatory purposes” provides specific internationally recognized requirements to certify the Quality Management System for medical device companies. It involves aspects of the ISO 9001 standard and additional requirements specific to the medical field, and it has been harmonized in compliance with the relevant European Directives – Medical Devices, In Vitro […]

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Great Success of ECM participation in Tel Aviv MDD event

Last 6th February, the annual convention dedicated to the medical field was held in Tel Aviv – Israel, focused on three main issues: Clinical Studies, Medical Device Regulation, Pharma Regulation. ECM has been invited to participate at the congress to bring its contribution in the regulatory field as Notified Body for EU Medical Device Directive and QMS 13485 […]

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JiT – Just in Time: Time to Market Matters! Delivering CE, ISO 13485 Certificate of Medical Devices in 3 Weeks

We are pleased to announce to the friends and supporters of ECM Notified Body and to the whole medical device industry the release of the JiT (Just in Time) CE, ISO 13485 Certification Service. JiT is no ordinary CE, ISO 13485 Certification Service. Quality, time to market, efficiency, versatility, cost effectiveness: all you require from […]

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ECM accepted as Newest Member of the TEAM-NB, the European Association for Medical devices of Notified Bodies

On10th April 2018, ECM Ente Certificazione Macchine was formally accepted as the newest member of TEAM-NB, the European Association for Medical devices of Notified Bodies. Team-NB was founded in 2001 and includes 24 Notified Bodies members from 12 different European countries. Membership in Team-NB represents an important international recognition and a great opportunity to advance dialogue with others Team-NB members. The primary […]

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How to Submit Technical Documentation: Reduce Time and Resources With ECM Guidelines

We are aware technical documentation is a crucial starting point for a quick, smooth and effective CE certification process. But submitting correct and complete technical documents is not easy for medical devices manufacturers, which must consider different aspects, from a regulatory point of view. What documents must be submitted? What are main contents to consider? […]

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