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.

Apr 11, 2011

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
Apr 12, 2011

FDA Weighs Classifying EHRs as Medical Devices

The US Food and Drug Administration (FDA) is considering whether to regulate electronic health records...
Apr 18, 2011

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)...
Apr 18, 2011

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...
Apr 20, 2011

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...
Apr 21, 2011

Regulatory Updates affecting the EU Market

The European Commission has issued a new version of the "Manual on Borderline and Classification...
Apr 21, 2011

New Guidance from FDA on 30-Day Notices

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has issued
Apr 25, 2011

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
Apr 25, 2011

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...
Apr 27, 2011

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.