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 4月 11日

EHTI Research Takes Aim at “Innovation Paradox” in EU Medtech Procurement Policy

New research by the European Health Technology Institute for Socio-Economic Research (EHTI) puts forth five recommendations to address the impact of more centralized medical technology procurement pol
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2011年 4月 12日

FDA Weighs Classifying EHRs as Medical Devices

The US Food and Drug Administration (FDA) is considering whether to regulate electronic health records (EHRs) as medical devices as it develops new rules targeting software, according to Center for Devices and Radiological Health (CDRH) director Dr. Jeffrey Shuren.
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2011年 4月 18日

BVMed Annual Report: Healthy Returns, but Stronger Regulatory Support for Innovation Needed

In its latest annual report , German medical device industry trade group BVMed (Bundesverband Medezintechnologie)...
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2011年 4月 18日

GAO Finds FDA’s Review and Safety Processes Inadequate

In April 13 testimony before the US Senate’s Special Committee on Aging, Government Accountability Office...
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2011年 4月 20日

FDA Grants Six-month Extension for Transition from Steris

The US Food and Drug Administration has allowed a six-month extension to health care facilities...
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2011年 4月 21日

Regulatory Updates affecting the EU Market

The European Commission has issued a new version of the "Manual on Borderline and Classification...
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2011年 4月 21日

New Guidance from FDA on 30-Day Notices

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has issued
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2011年 4月 25日

New Guidelines for Medical Technology Issued in the UK

The National Institute for Health and Clinical Excellence (NICE), an organization providing health care-related guidances and standards in the UK, has
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2011年 4月 25日

FDA’s Office of Combination Products Revises Guidance on RFD Submissions

The US Food and Drug Administration’s Office of Combination Products (OCP) has updated its guidance on Request for Designation (RFD) documents submitted by manufacturers or their sponsors in order to determine how to classify their devices. The revised guidance spells out more clearly what information the OCP requires within an RFD in order to more promptly determine whether a product should be regulated as a drug, device, biological product or combination product.
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2011年 4月 27日

ANVISA Accepting Public Comments for New Medical Device Grouping Criteria

Medical device manufacturers interested in submitting comments to Brazilian regulator ANVISA regarding proposed new grouping criteria have until May 8 to do so.
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