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.

Jan 11, 2011

Single Medical Research Regulatory Framework Championed in the UK

The UK’s Academy of Medical Sciences has issued a new report recommending the consolidation of medical research regulations and governance under a single entity. The Academy’s report, “A new Pathway for the Regulation and Governance of Health Research,” includes five key components:
Jan 10, 2011

Med-tech Buying Binge to Accelerate

Some of the medical device industry’s biggest manufacturers intend to step up acquisitions in order to expand their product lines in 2011. Following $10 billion worth of deals last year, 2011 shoul
Jan 7, 2011

Medical Device Industry Revenues Could Exceed $300 Billion This Year

The global medical device market will reap $312 billion in revenues in 2011 according to estimates from Kalorama Information, a life sciences market research provider in New York. In a new report,
Jan 6, 2011

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,
Jan 6, 2011

Survey: Prosperous Year Ahead for Medical Device Industry

Prospects look healthy for the global medical device industry according to results of the 2011...
Jan 5, 2011

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.
Jan 5, 2011

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
Jan 5, 2011

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...
Dec 28, 2010

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
Dec 21, 2010

EC Report: Joint Replacement Surgeries on the Rise

A new report issued by the European Commission and the Organization for Cooperation and Economic...