Egypt fast-track medical device registration pathway speeds up market access timeframes

Emergo GroupBy Stewart Eisenhart, Emergo Group

A fast-track premarket review pathway for some medical devices in Egypt is yielding substantially reduced time to market for qualifying manufacturers.

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 not necessarily reflect those of MassDevice.com or its employees.

U.K. government requests Brexit deadline extension

Emergo GroupBy Ronald Boumans, Emergo Group

The U.K. government has requested a further delay in implementing its withdrawal from the European Union, with an April 12 deadline for a no-deal Brexit outcome fast approaching.

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 not necessarily reflect those of MassDevice.com or its employees.

Canadian regulators clarify changes in qualifications for medical device licenses following Sterigenics shutdown

Emergo GroupBy Stewart Eisenhart, Emergo Group

Canadian medical device regulator Health Canada has issued a clarification on which changes to Medical Device License (MDL) holders’ sterilization processes constitute “significant changes” following the closure of a major sterilization facility in the US earlier in 2019.

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 not necessarily reflect those of MassDevice.com or its employees.

5 issues for medical device risk management and design controls

Emergo GroupBy Mark Leimbeck, Emergo Group

Medical device design and development processes in the context of risk management require careful consideration and planning by manufacturers. Following our webinar in early 2019, we explore five key issues companies face when linking design and development with risk management and, ultimately, patient safety.

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 not necessarily reflect those of MassDevice.com or its employees.

FDA identifies hundreds of device types affected by sterilization facility closures

Emergo GroupBy Stewart Eisenhart, Emergo Group

The US Food and Drug Administration has identified nearly 600 types of medical devices possibly impacted by the recent shutdown of a sterilization facility in the midwestern US, and states that a second sterilization facility will also close this year.

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 not necessarily reflect those of MassDevice.com or its employees.

Japan increases medical device registration fees

Emergo GroupBy Stewart Eisenhart, Emergo Group

Japan’s Pharmaceutical and Medical Devices Agency (PMDA) has increased registration, inspection and related regulatory fees for medical device market applicants.

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 not necessarily reflect those of MassDevice.com or its employees.

FDA recommendations from the annual Human Factors and Ergonomics Society symposium

Emergo GroupBy Erin Davis and Allison Strochlic, Emergo Group

Manufacturers, consultants, researchers, and regulators all descended upon Chicago this week for the annual Human Factors and Ergonomics Society Health Care Symposium. After taking in dozens of oral presentations and hundreds of posters, attendees often walk away from the event feeling invigorated that there are so many human factors (HF) professionals out there working to make medical technology, as well as clinical care environments, safe, effective, and satisfying.

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 not necessarily reflect those of MassDevice.com or its employees.

The post FDA recommendations from the annual Human Factors and Ergonomics Society symposium appeared first on MassDevice.

How medical device human factors researchers can ensure GDPR compliance

Emergo GroupBy Stewart Eisenhart, Emergo Group

Following Emergo by UL’s recent webinar on the European Union’s General Data Protection Regulation (GDPR) and human factors studies for medical devices, we examine key GDPR compliance issues human factors researchers must address to avoid steep penalties. The webinar was presented by Allison Strochlic and Alexandria Trombley, Research Director and Human Factors Specialist, respectively, at Emergo by UL’s Human Factors Research & Design (HFR&D) division, as well as two legal experts from Sidley Austin, Geraldine Scali and Kate Heinzelman.

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 not necessarily reflect those of MassDevice.com or its employees.

The post How medical device human factors researchers can ensure GDPR compliance appeared first on MassDevice.

FDA targets safety of medical device materials

Emergo GroupBy Stewart Eisenhart, Emergo Group

US medical device regulators are planning more focused evaluations of materials used in the manufacture of medical devices for safety issues.

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 not necessarily reflect those of MassDevice.com or its employees.

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FDA reviews requirements for nicotine replacement therapy product labels

Emergo GroupBy Stephanie Larson and Richard Featherstone, Emergo Group

Nicotine replacement therapy (NRT) drug products, such as patches, gum and lozenges, have been around for more than 30 years. More novel products such as e-cigarettes provide additional choices for people using NRT for smoking cessation. But, like any other drug delivery mechanism, there are risks as well as benefits when using NRT drug products. While the technology has been marching ahead, regulators have been taking an increased interest in how to manage the risks of harm associated with using such products.

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 not necessarily reflect those of MassDevice.com or its employees.

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