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 2月 4日

FDA's Approach to Mobile Devices Becoming Clearer

The US Food and Drug Administration (FDA) has cleared two mobile applications for use as medical devices, potentially answering broader industry questions about how the regulator would view such products as they become more frequently used for health care-related purposes.
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2011年 2月 7日

Jaw Implants under FDA Scrutiny

Jaw implant manufacturers are apparently the latest segment of the medical device industry to experience the new get-tough stance by US regulators. The three major manufacturers of temporomandibula
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2011年 2月 8日

New Program Could Halve PMA Processing Time for Innovative Devices

In an effort to foster development of cutting-edge medical device technologies, the US FDA has proposed a new program,
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2011年 2月 14日

FDA’s New MDDS Rule Finalized

Final rules to expedite medical device data systems’ (MDDS) path to market in the US have been issued<
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2011年 2月 15日

Recall Study Results Suggest 510(k) Reform Needed

A new study examining high-risk recall rates of medical devices in the US as added weight to contentions that the Food and Drug Administration’s
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2011年 2月 16日

Certain IVDs Now Subject to Application Audits by Australia’s TGA

The Therapeutic Goods Administration (TGA), Australia’s medical device regulator, has specified which in vitro devices (IVDs) will be required to undergo
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2011年 2月 16日

US Congress Wading into FDA Reform Debate

Opponents of the Food and Drug Administration’s reform efforts targeting medical device reviews have a sympathetic ear in Joe Pitts, the Republican congressman from Pennsylvania who now chairs the Hou
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2011年 2月 17日

Eucomed Proposes Wider Adoption of Remote Cardiac Device Monitoring Tools

European medical device trade association Eucomed has made adoption of technology to remotely monitor implantable cardiac devices a key element of its four recently submitted proposals to the European Commission Innovation Union Strategy's Active and Healthy Ageing Innovation Partnership program.
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2011年 2月 18日

Battle Lines Drawn in Congressional Hearing on FDA Review Process

Business-friendly US lawmakers and the FDA’s Center for Devices and Radiological Health director Dr.
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2011年 2月 25日

EU: Broad Support for IVDD Revisions

Comments following European Union regulators’ public consultation on proposed revision to Directive 98/79/EC indicate
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