Blog

The Role of a PRRC (Person Responsible for Regulatory Compliance) in the EU MDR

The Role of a PRRC (Person Responsible for Regulatory Compliance) in the EU MDR The New EU MDR that will go into effect in May 2020 requires medical device companies to appoint a Person Responsible for Regulatory Compliance (PRRC). The PRRC does not replace the requirement for a European Authorized Representative (EC Rep). The role […]

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The MDR Countdown

The MDR Countdown The new EU Medical Device Regulation (MDR) will create a robust, transparent, and sustainable regulatory framework, recognized internationally, that improves clinical safety and creates fair market access for manufacturers. Manufacturers need to start now and prepare for this substantial and unprecedented change in the European regulatory environment for medical devices – or […]

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Will Your Notified Body Be Ready for Your EU MDR Certification?

Will Your Notified Body Be Ready for Your EU MDR Certification? With the May 26, 2020 enforcement deadline for compliance with the Medical Device Regulation (EU MDR) approaching and the uncertainty of Brexit, medical device manufacturers and regulatory professionals are facing difficult moments. Notified Bodies around the world, as well as medical device companies are […]

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ECM’s Milestone Towards New Medical Device Regulation (MDR) 2017/745 Certification

ECM’s Milestone Towards New Medical Device Regulation (MDR) 2017/745 Certification Medical device manufacturers are now focusing their attention on their transition plans to the new MDR regulations which becomes mandatory on May 25, 2020.  In addition, some manufacturers may be in a pickle in a few months if their Notified Body (NB) is not already […]

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FIME EXPO Spurs Medical and Healthcare Innovation in June

FIME EXPO Spurs Medical and Healthcare Innovation in June FIME (Florida International Medical Expo) will host its 29th show at the Miami Beach Convention Center in Miami Beach, Florida from June 26-28, 2019. FIME’s reputation takes top spot among medical and healthcare trade professionals where over 22,400 visitors from around the world do business, seek […]

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Countdown to Brexit

Countdown to Brexit If your medical devices are CE certified by a British Notified Body, the wisest choice could be to transfer the CE to a Notified Body based in the Union, to avoid regulatory troubles and any other issues related to a no-deal scenario. ECM is a Notified Body based in Italy, with commercial […]

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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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Great Success of ECM’s ON TIME Service!

Great Success of ECM’s ON TIME Service! We are collecting more and more positive reviews from our customers, satisfied to have successfully obtained the CE certification for their devices thanks to the ECM On Time Service. Through a pre-assessment and subsequent ONSITE review and audit, in order to engage in a dynamic discussion with the […]

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ECM Program Supports Entrepreneurial Innovation in the Medical Device Market

  ECM Program Supports Entrepreneurial Innovation in the Medical Device Market   One of the most daunting challenges for startup entrepreneurs in the medical device industry is understanding the complex requirements to achieve regulatory compliance through the design, submission and post market stages.  Anyone who does not meet the strict and multifaceted regulatory requirements throughout a […]

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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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ECM’s Top Ten

Besides all the medical devices that we can certify, ECM has gained a strong experience in specific products, for which we have carried out many activities of evaluation and certification of CE conformity. If your medical device is on the list, we are the perfect Notified Body for you! 1. Catheters 2. Oxygen Mask 3. […]

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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

  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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Solve the math of regulatory time!

  In the rapid paced medical device market, time-to-market is critical. Any delay in getting your device to market will negatively impact revenue and market share, add significant staffing costs, and can reflect negatively on your brand. There can be many speed bumps along the road to regulatory approval. On Time Service from ECM is […]

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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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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