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.

2012年 8月 22日

Big changes in the world of EU harmonized standards

We note that there is considerable change in the world of harmonized standards.
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2012年 8月 23日

Important changes to US FDA establishment registration requirements

There are important changes coming soon from the US FDA that may affect your company...
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2012年 8月 29日

New Whitepaper Urges Better Reimbursement Process for CIED Telemonitoring in Europe

European Union regulators must develop a robust country-level reimbursement framework for remote monitoring of cardiac implantable electronic devices (CIED), according to a new whitepaper by PriceWaterhouseCoopers, the European Heart Rhythm Association (EHRA) and Eucomed.
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2012年 9月 5日

New European Norm Harmonized Standards Go Into Effect

There are big changes in the world of European Norm harmonized standards!
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2012年 9月 7日

ANVISA, Brazil’s medical device market regulator, has ended a months-long strike

ANVISA, Brazil’s medical device market regulator, has ended a months-long strike that had complicated foreign manufacturers’ importation and commercialization efforts in the country.
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2012年 9月 12日

FDA Details New Medical Device Registration and Listing Requirements

The US Food and Drug Administration has published a list of frequently asked questions regarding
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2012年 9月 13日

MDA Solicits Comment on Draft Medical Device Regulations in Malaysia

The Medical Device Authority (MDA), Malaysia’s nascent medical device regulatory agency, has published a
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2012年 9月 20日

SFDA to Utilize Surprise Inspections of Medical Device Manufacturers in China

Recent regulations implemented by China’s State Food and Drug Administration (SFDA) now allow unannounced inspections...
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2012年 9月 21日

US FTC Issues Advertising, Privacy Guidelines for Mobile Medical App Makers

It’s not just the US Food and Drug Administration mulling over how to regulate mobile medical applications these days. The US Federal Trade Commission (FTC) has also recently come out with guidelines for medical app developers targeting advertising and privacy issues. The FTC recommendations cover basic legal requirements that medical app manufacturers must meet in order to market their products, introducing obligations for these companies to be met along with FDA medical device registration requirements.
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2012年 10月 1日

FDA Urged to Develop Security Plan for Wireless Implantable Medical Devices

The US Government Accountability Office (GAO) has issued recommendations that the Food and Drug Administration develop a comprehensive plan to improve the agency’s ability to review and monitor active implantable medical devices that rely on wireless and other advanced technologies.
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