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 5月 16日

CDRH Steps Up Vigilance of Genetic Testing Product Sector

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has issued letters to
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2011年 5月 16日

Recast of EU’s Hazardous Material Regulations to Impact Medical Devices

The European Union’s Restriction on Hazardous Substances (RoHS) Directive covering electronic devices will soon also cover medical devices. The law has been fashioned to improve collection and recycling rates of electronic devices across the EU, as well as to cut down on illegal exporting of electronic waste products from the EU.
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2011年 5月 18日

ESC Advocates Single EU System for Medical Device Regulation

The European Society of Cardiology (ESC) has published a position pap
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2011年 5月 19日

Medical Device Trade Groups Sign On to Global Compliance Statement

Nine medical device industry associations have signed on to the Global Compliance Statement on Interactions Between Medical Technology Companies and Healthcare Professionals (HCPs), a document intended to promote ethically sound interactions between the groups’ member firms and health care providers.
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2011年 5月 20日

New Study Identifies Five Principles of Effective Medical Device Procurement

A new study published in the Journal of Medical Marketing lists five key principles necessary to develop sound medical t
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2011年 5月 20日

Code of Conduct for Notified Bodies Goes Public

Notified Bodies BSI, TÜV Rheinland, TÜV SÜD, LNE-GMED and DEKRA/KEMA have made public a code of conduct they drafted earlier this year in accordance with Directives 90/385/EEC and 93/42/EEC.
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2011年 5月 23日

CDRH: 577 Warning Letter Cites Issued in 2010

The US FDA’s Center for Devices and Radiological Health has released data on warning letter cites regarding manufacturers’ quality system deficiencies in 2010.
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2011年 5月 24日

Another Survey Shows US Regulatory Structure Undermining Innovation

A new survey conducted by Northwestern University and funded by the Institute for Health Technology...
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2011年 5月 25日

FDA Undertaking Long-term Evaluation of How Medical Devices Interact with Other Appliances

The US Food and Drug Administration’s years-long effort to evaluate how medical devices are impacted by electromagnetic waves emitted by microwaves, security scanners and other appliances has been spotlighted in a new report by The Wall Street Journal .
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2011年 5月 27日

House Republicans Propose 12% Cut to FDA Budget

The US House of Representatives’ Appropriations Committee has issued a 2012 spending bill cutting the Food and Drug Administration’s budget by $285 million, or 11.5%.
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