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 10日

Eucomed Issues Position Paper on eHealth

European medical technology industry trade group Eucomed has published a position paper on eHealth issues as the European Ministerial eHealth Conference gets underway in Budapest.
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2011年 5月 10日

Brazil Inspection Fees

Brazil’s National Agency for Sanitary Surveillance (ANVISA) has officially confirmed that inspection fees for Certificates of Good Manufacturing Practice and Quality Control (Brazil GMP) will
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2011年 5月 10日

Iceland Sets Transfers Medical Device Oversight to IMA

The Icelandic government has transferred oversight of the country’s medical device sector to the Icelandic Medicines Agency (IMA) from the D
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2011年 5月 11日

FDA Orders Post-market Studies of Metal-On-Metal Hip Replacement Devices

The US Food and Drug Administration has ordered all manufacturers of “metal-on-metal” artificial hip devices to conduct post-market studies to see whether the implants are malfunctioning or causing health problems in patients.
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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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