Regulatory
5 Questions About Device-Drug Combo Products
Feb 03, 2012
Mark Kramer answers 5 questions on comination products and the regulatory hurdles manufacturers can face. 1. What is a combination product? A combination...
European Commission Conducts Stress Test in Wake of Pip Breast Implant Scandal
Feb 03, 2012
On the heels of a scientific study on faulty breast implants manufactured by French company Poly Implant Prothèse (Pip), the European Commission (EC)...
Russia Plans to Release New Medical Device Regulations
Jan 27, 2012
Impending new medical device regulations in Russia are expected to make the regulatory system more streamlined. The regulations are expected to be released in...
European Commission Publishes Guidance on Stand-Alone Medical Software
Jan 25, 2012
The much-anticipated (and unbelievably wordy) "MEDDEV 2.1/6: Guidelines on the Qualification and Classification of Stand-Alone Software Used in...
Japan's Medtech Regulatory Body Goes Back to School
Jan 25, 2012
Change seems to be afoot in Japan's regulatory approach to medical technology. Nothing dramatic yet, but, as Japan Medical Design and Manufacturing Technology...
Nuvasive CEO: FDA's Policies Could Cost Company $70 Million
Jan 13, 2012
 Alex Lukianov On January 10, PricewaterhouseCoopers, the California Healthcare Institute, and BayBio released early results of the California...
Survey: Majority of Biomedical Companies Cutting R&D Projects
Jan 11, 2012
On January 10, PricewaterhouseCoopers, the California Healthcare Institute, and BayBio released preliminary findings of its California Biomedical Industry 2012...
The Medtech Leader Perspective on Globalization at OneMedPlace Conference
Jan 11, 2012
The OneMedPlace finance conference in San Francisco featured a panel discussion titled "AdvaMed 2012 CEO’s Unplugged: Global Outlook on Medical...
Expert Calls Europe's Regulatory Frame a Smokescreen
Jan 11, 2012
In an interview with BBC, Richard Horton, MD, editor of the Lancet medical journal lambasted the EU regulatory process for medical devices, citing the recent...
For Medtech Firms, Things to Keep in Mind when Doing Business in China
Jan 09, 2012
It is well understood that China is a country marked by dramatic change. One of the observations shared at the China Forum at OneMedPlace today in San...