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 6月 24日

Draft Guidance on Human Factors and Usability Engineering Issued by FDA

The US Food and Drug Administration (FDA) has published a 37-page draft guidance for industry on proper human factors testing and medical device design optimization.
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2011年 6月 29日

IBM Survey Finds Growing Consumer Demand for Mobile Health Devices

A new survey by the IBM Institute for Business Value indicates high satisfaction rates among patients and caregivers using mobile medical devices, as well as growing willingness to spend money for such devices.
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2011年 7月 1日

Health Canada Elaborates on IEC 60601-1 Compliance Recommendations

Health Canada has provided recommendations for medical device manufacturers whose products must comply with the latest iteration (Third Edition) of the IEC 60601-1 medical electrical equipment safe
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2011年 7月 8日

New TGA website & ANZTPA Back on Track

In addition to a redesign of the TGA website and the latest fee schedule, there are some exciting new developments in the effort to form a unified regulatory system between Australia and New Zealand.
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2011年 7月 12日

FDA Proposes Exempting Some In Vitro Devices from 510(k) Review

New draft guidance from the US Food and Drug Administration would reclassify some in vitro...
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2011年 7月 12日

New Adverse Event Reporting Guidelines from GHTF

The Global Harmonization Task Force’s (GHTF) has issued guidance establishing a uniform, global system for adverse event reporting during pre-market clinical investigations of medical devices.
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2011年 7月 15日

AdvaMed Study: Competition Keeping US Medical Device Pricing Low

A new study by US medical device industry lobbying group Advanced Medical Technology Association (AdvaMed) finds that prices for medical devices and diagnostic products have increased at less than one-fourth the rate of other medical products and services due to high pricing competition.
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2011年 7月 15日

Volume of FDA Warning Letters to Keep Increasing

The growing rate of US Food and Drug Administration inspections and warning letter issuances, already higher than last year, will continue to increase according to a report by FDANews.com (subscription required).
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2011年 7月 18日

Mexico to Ease IVD Registration Process

Mexican medical device regulators plan to establish simplified registration for in vitro diagnostics and other low-risk products, and to exempt another 1,700 health products from medical device reg
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2011年 7月 19日

Finally, Draft FDA Guidance on Mobile Medical Apps

Highly anticipated draft guidance on mobile medical applications has been published by the FDA’s Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER). Targeting specific subsets of mobile medical device applications , the guidance should help answer some longstanding industry questions of how—or whether—US and other regulators would approach such devices. The guidance could furthermore serve as a template for other medical device market regulators determining how to establish requirements for this burgeoning sector of the device industry.
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