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 1月 6日

FDA Launches Website for Better Industry Communication

In an effort to foster more transparency and communication with the industries it regulates, the FDA has launched a new website,
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2011年 1月 6日

Survey: Prosperous Year Ahead for Medical Device Industry

Prospects look healthy for the global medical device industry according to results of the 2011...
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2011年 1月 5日

Changes Ahead for FDA’s Informed Consent Requirements

FDA regulations dictating informed consent requirements for drug and medical device clinical trials are set to change on March 7, 2012.
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2011年 1月 5日

Sharfstein Out at FDA

The FDA’s second-in-command Joshua Sharfstein is stepping down as principal deputy commissioner to become Maryland’s secretary of health and mental hygiene, according to
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2011年 1月 5日

FDA Proposes Recordkeeping Requirements for Third-party 510(k) Reviewers

The US Food and Drug Administration (FDA) has proposed (Docket No. FDA–2010–N–0447) new rules targeting...
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2010年 12月 28日

New Adverse Event Reporting Guidelines for Europe

The European Commission has issued new guidelines for how entities conducting clinical trials should report serious adverse events to appropriate national competent authorities (NCAs). The new rele
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2010年 12月 21日

EC Report: Joint Replacement Surgeries on the Rise

A new report issued by the European Commission and the Organization for Cooperation and Economic...
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2010年 12月 15日

European Court Limits Member States’ Authority over Medical Device E-Commerce

The European Court has recently ruled to limit member states’ authority to restrict medical
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2010年 12月 15日

EU Unveils New Medical Device Clinical Investigation Guidelines

New medical device guidelines, MEDDEV 2.7.4 , addressing clinical investigations have been issued in the Eu
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2010年 12月 15日

40-year EU Patent Impasse at an End?

The European Patent Office (EPO), the European Commission body theoretically responsible for evaluation of patent applications, appears closer than at any point in the last 40 years to achieving a mor
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