where we are

    ECM Shanghai and Mid-Link Group, a successful collaboration starting from CMEF CMEF Spring 2019 – the largest Asia Pacific’s medical device trade show – has successfully closed on May 17. With 120.000 visitors coming from 150 countries, 4.200 exhibitors on over 220,000 sqm exhibition space, more than 600 new products and technologies launched at the fair, the 81st China International Medical Equipment Fair confirms its absolute leadership as one of the world’s top events for the healthcare industry.
    ECM Shanghai, which participated as exhibitor together with Mid-Link Group, has provided the attendees with their competence in the field of medical devices, collecting great interest from manufacturers.
    “For this important event, we took the great opportunity to launch the cooperation with the major Chinese firm, Mid-Link Group, leader in global regulatory strategies and testing services” says the ECM Shanghai General Manager Marco Morina. “Thanks to this prestigious collaboration” continues Mr. Morina “we can provide the market with a high-quality service, covering a wide range of devices categories.”
    With the approach of the new Regulation MDR 2017/745 in 2020, ECM addresses producers, who are increasingly expressing their concerns about the new market challenges. “Aware of the difficulties that companies are currently facing related to the transition to the new MDR” explains Mr. Morina “ECM still accepts application under MDD. This allows manufacturers to gain precious time to comply with the new MDR requirements, with lower risk” concludes our General Manager from ECM Shanghai.
    ECM Ente Certificazione MacchineItalian Notified Body for MDD 93/42/CE (and many other directives), accredited ISO 13485 Certification Body and accredited Testing Laboratory, has already applied for MDR accreditation, in order to extend the certification scope to 80% and is now waiting for the joint assessment of the competent authorities. ECM provides the medical devices industry with a wide range of certification, testing, audit and training activities. 
    To submit your request:
    Shanghai Office ecmshanghai@entecerma.cn.it | +86 (0) 21.68827718 | www.entecerma.cn.it
    ECM Italy – Headquarter info@entecerma.it | www.entecerma.it

    [In the picture from the left, Marco Morina General Manager ECM Shanghai, Diana Hong President of Mid-Link, ​Roger Chen Chief Executive Manager ECM Shanghai]

    #ECMShanghai #medicaltradefair #regulatoryaffairs #testing #medicaldevicecertification #CMEF #ChinaInternationalMedicalEquipmentFair

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