Affiliate Program for Medical Device CE Marking

ECM is launching a special affiliation program dedicated to medical device consulting companies! Do you want to take advantage of a partnership with a uniquely progressive and widely recognized European Notified Body? What are the benefits of cooperating with an accredited certification body? ECM can provide you with high competence, official standing and international visibility. […]

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URGENT BREXIT NEWS

URGENT BREXIT NEWS:  If you are certified by a British Notified Body, you could lose your CE Certificate in 60 days. It has been confirmed that in case of a No-Deal outcome for Brexit on March 29th, 2019, all CE certificate issued by Notified Bodies based in the UK will become invalid. This means that […]

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Application for MDR 2017/745 accreditation: latest updates!

Application for MDR 2017/745 accreditation: latest updates! Last week, a further step towards the designation as Notified Body for the Medical Device Regulation 2017/745 was successfully achieved. Our application has passed the first stage of examination by the Italian authorities and has been sent to the European Commission. We are now waiting for the work […]

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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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