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 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 10月 7日

Parallel Review Pilot for Innovative Devices Launched by FDA and CMS

A parallel review pilot program newly deployed by the US FDA and the Centers for Medicare & Medicaid Servic
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2011年 10月 7日

New Study: US Med Tech Industry Losing VC Funding

Venture capital firms are investing less in US medical device and pharmaceutical companies in favor...
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2011年 10月 6日

CDRH Sets Up Pilot Program on Establishing Panel of Outside Experts

The US FDA’s Center for Devices and Radiological Health (CDRH) has launched a 12-week pilot program on it
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2011年 10月 3日

FDA Unveils Two-Option De Novo Approach

The US Food and Drug Administration has published draft guidance establishing two pathways for medical...
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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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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 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 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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