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Emergo Group

New Croatian notified body designated to European MDR

December 23, 2020 By Danielle Kirsh

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By Ronald Boumans, Emergo Group UDEM Adriatic d.o.o., based in Zagreb, Croatia, is a new name in the EU Notified Body community. They have been officially listed in the European database for Notified Bodies, NANDO, designated for the upcoming Medical Devices Regulation (EU) 2017/745 (MDR). Their Notified Body number is 2696. UDEM is not listed […]

Filed Under: Regulatory/Compliance Tagged With: blog, Emergo Group

Ensuring safe and effective distribution of COVID-19 vaccines

December 21, 2020 By Danielle Kirsh

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By Stewart Eisenhart, Emergo Group As governments, industry and other entities begin COVID-19 vaccine distribution efforts worldwide, cold chain management has emerged as a crucial factor for ensuring vaccine safety and effectiveness. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do […]

Filed Under: Pharmaceuticals Tagged With: blog, Emergo Group

Clinical study sponsors may become non-EU post-Brexit

December 8, 2020 By Danielle Kirsh

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By Ronald Boumans, Emergo Group The departure of the United Kingdom from the European Union on January 1, 2021, has many consequences. Clinical investigations with medical devices as well as clinical performance studies with in vitro diagnostic devices are impacted, as are clinical studies with medicinal products. In this respect, Brexit means that sponsors and […]

Filed Under: Regulatory/Compliance Tagged With: blog, Emergo Group

Key steps for medical device manufacturers effective CAPA management

November 19, 2020 By Danielle Kirsh

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By Sarah Fitzgerald and Stewart Eisenhart, Emergo Group Ensuring adequate processes for corrective and preventative action (CAPA) management is a critical step for medical device manufacturers implementing ISO 13485:2016 or other quality management systems. However, effective CAPA management can prove a perennial challenge even to larger, more mature manufacturers. Get the full story here at […]

Filed Under: Regulatory/Compliance Tagged With: blog, Emergo Group

MDSAP council updates guidance on conformity assessments and related requirements

November 5, 2020 By Danielle Kirsh

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By Timothy Herr, Emergo Group Participating regulatory bodies in the Medical Device Single Audit Program (MDSAP) published a new consolidated guidance document, MDSAP AU P0002.005 Audit Approach, which combines the former MDSAP Audit Model and Process Companion Document​ into a single source of information detailing the process for auditing the quality management systems of medical […]

Filed Under: Regulatory/Compliance Tagged With: blog, Emergo Group

Chinese regulators delay medical device UDI implementation

October 15, 2020 By Danielle Kirsh

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By Stewart Eisenhart, Emergo Group China’s National Medical Products Administration (NMPA) has extended the trial period for its medical device unique device identification (UDI) program in response to the coronavirus pandemic, pushing first-round UDI implementation requirement deadlines to early 2021. Get the full story here at the Emergo Group’s blog. The opinions expressed in this […]

Filed Under: Regulatory/Compliance Tagged With: blog, Emergo Group

MDR mutual recognition agreement unresolved after Swiss referendum

October 14, 2020 By Danielle Kirsh

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By Ronald Boumans, Emergo Group On September 27, 2020, the Swiss held one of their many referendums. Due to the COVID-19 pandemic the referendum in May 2020 had been postponed. This resulted in a total of five issues they were asked their opinion about, so the Swiss had to do a bit of homework before […]

Filed Under: Regulatory/Compliance Tagged With: blog, Emergo Group

Japan PMD Act revises fast-track reviews for some medical devices, IVDs

September 23, 2020 By Danielle Kirsh

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By Stewart Eisenhart, Emergo Group Significant revisions to Japanese regulations of medical devices, IVDs and other healthcare products have begun taking effect, with phased implementations (link in Japanese) of new and updated requirements planned through 2022. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the […]

Filed Under: Regulatory/Compliance Tagged With: blog, Emergo Group

Understanding clinical evidence requirements under European Medical Devices Regulation

August 19, 2020 By Danielle Kirsh

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By Dietmar Falke, Emergo Group The European Medical Devices Regulation (MDR) demands that “confirmation of conformity with relevant general safety and performance requirements under the normal conditions of the intended use of the device, and the evaluation of the undesirable side-effects and of the acceptability of the benefit-risk-ratio, shall be based on clinical data providing […]

Filed Under: Regulatory/Compliance Tagged With: blog, Emergo Group

How COVID-19 impacts FDA interactions with medical device manufacturers

July 2, 2020 By Danielle Kirsh

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By Stewart Eisenhart, Emergo Group The US Food and Drug Administration may revise performance goals and timelines set under the Medical Device User Fee Amendments IV (MDUFA IV) as emergency efforts targeting the coronavirus pandemic take up more of the agency’s time. Get the full story here at the Emergo Group’s blog. The opinions expressed […]

Filed Under: Regulatory/Compliance Tagged With: blog, Emergo Group

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