As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That is why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you.

2011年 9月 9日

CDRH Issues Additional Import Entry Review Process Recommendations

The US FDA’s Center for Devices and Radiological Health (CDRH) has issued an Letter to...
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2011年 9月 14日

FDA Mobile Apps Workshop: Panelists Grapple with Apps-as-Accessories Issue

During the US Food and Drug Administration’s two-day public workshop on its Mobile Medical Applications Draft Guidance held September 12 and 13, 2011, attendees and FDA officials wrestled with the issue of how to classify applications that serve as accessories to medical devices.
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2011年 9月 14日

FDA Mobile Apps Workshop: Can App Developers Meet Medical Device Requirements?

Can minimally-staffed software application developers getting into the medical device sector reasonably be expected to comply with the same FDA requirements as medical device manufacturers?
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2011年 9月 14日

FDA Mobile Apps Workshop: Getting a Handle on Clinical Decision Support Systems

Mobile medical app-related issued explicitly not covered by the recent FDA guidance’s scope include wireless safety, applying quality systems to software and regulatory requirements for clinical decision support (CDS) software. The agency has disclosed plans to address these issues in separate guidances, but has provided no further details on those plans.
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2011年 9月 16日

HC Amends Procedure for Mandatory Problem Reports

Canadian medical device market regulator Health Canada will begin requiring manufacturers and importers to send Mandatory Problem Reports (MPRs) to its Health Canada Vigilance-Medical Device Progra
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2011年 9月 23日

InMedica Report: Global Telehealth Market to Top $1 Billion by 2016

The worldwide market for telehealth products and services will reach more than $1 billion by 2016—and may reach $6 billion by 2020—according to a new study by medical electronics market research provider InMedica.
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2011年 9月 27日

MEDEC Reports Lower Application Volumes, Longer Delays at MDB

Canadian medical technology industry trade group MEDEC has found both decreasing volumes of applications sent to Health Canada’s Medical Devices Bureau (MDB) in the second quarter of 2011 as well as delayed market authorizations for the bulk of submitted applications due to recent regulatory changes.
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2011年 9月 28日

Eleven Notified Bodies Sign On to Code of Conduct

A voluntary code of conduct for European Notified Bodies appears to be gaining traction following the document’s publishing in early 2011. Medtechinsider.com reports that eleven Notified Bodies have now signed the code of conduct ahead of a highly anticipated recast of the European Medical Devices Directive.
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2011年 9月 29日

GHTF Publishes Unique Device Identification Guidance for Regulators

The Global Harmonization Task Force (GHTF) has issued final guidance on developing a global Unique Device Identification (UDI) system for medical devices.
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2011年 9月 30日

HC Plans Wider Use of Foreign Reviews in Device Licensing Process

Health Canada has published draft guidelines outlining plans to make broader use of medical product...
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