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 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
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.
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...
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,
2011年 1月 7日

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,
2011年 1月 10日

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
2011年 1月 11日

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:
2011年 1月 12日

Brazil: New Reimbursement System in the Works

The Brazilian National Congress’s Committee on Constitution and Justice and Citizenship has approved the incorporation of medical treatments and equipment into new reimbursement rules under the countr
2011年 1月 14日

FDA Issues Draft Guidance on Electronic Documentation

The US Food and Drug Administration (FDA) has recently published a draft guidance, “Electronic Source...
2011年 1月 17日

POC Device Market Doubled in Six Years

According to new research from Kalorama Information, the point-of-care testing market reached $13.3 billion worldwide...