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 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 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 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 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 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 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 2日

Canada’s MDB Struggled to Meet Market Authorization Timelines in 2010

According to MEDEC, the Canadian medical device industry trade association, Health Canada’s Medical Devices Bureau (MDB) faced a persistent backlog last year when it came to processing
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2011年 1月 31日

FDA Panel: ECT Devices Require Further Testing

The US Food and Drug Administration’s Neurological Devices Advisory Committee came out last week in support of further testing of devices used in electroconvulsive therapy (ECT). ECT devices used i
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2011年 1月 28日

AdvaMed-sponsored Study: FDA Less Efficient than EU Regulators

A new study sponsored by the US medical device industry trade association Advanced Medical Technology Association (AdvaMed), “EU Medical Device Approval Safety Assessment,” has found that the European regulatory system has performed just as effectively in terms of public safety as the US Food and Drug Administration while simultaneously providing a speedier and more efficient path to market for manufacturers.
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2011年 1月 27日

HC Clarifies Significant Change Guidance

Health Canada has published new guidance defining when manufacturers’ altering of their Class III and Class IV devices constitutes “significant change,” affecting
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