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- Quality System Development in Medical Device Start-Ups
- The medical device industry, with its broad spectrum of product technologies and medical applications, is characterized by innovation from small, often start-up, and companies. Medical device start-ups are challenged by limited resources, yet they must develop their technology, product and business strategy and simultaneously develop a quality system that is...
- White papers 2004-07-26
Additional Resources
- Synteract Expands Consulting Offerings to VC Funding Biopharmaceutical Start-ups
- Wireless News 06-12-2009 Synteract Expands Consulting Offerings to VC Funding Biopharmaceutical Start-ups Type: News Synteract, a full-service contract research organization CRO dedicated to meeting the clinical research, technology, and safety needs of biotechnology, medical device, and pharmaceutical companies, has expanded its consulting...
- Research articles 2009-06-12
- Synteract Extends Consulting Services to VCs Funding Biopharmaceutical Start-ups
- Wireless News 06-15-2009 Synteract Extends Consulting Services to VCs Funding Biopharmaceutical Start-ups Type: News Synteract, Inc., a contract research organization CRO dedicated to meeting the clinical research, technology, and safety needs of biotechnology, medical device, and pharmaceutical companies, has expanded its consulting...
- Research articles 2009-06-15
- Synteract Offers Consulting Expertise to Venture Capitalists Funding Biopharmaceutical Start-ups
- Clinical Contract Research Organization Provides Incubator Expertise to Mitigate Risk Factors SAN DIEGO -- Synteract, ...
- Research articles 2009-06-10
- ISRAEL: RESPERATE DEVICE TO BE MARKETED.(in United States)(Brief Article)
- Medical devices company InterCure said it has received U.S. Food and Drug Administration FDA approval to market its RESPeRATE device to lower high blood pressure, GLOBES reported. ... Medical devices company InterCure said it has received U.S. Food and Drug Administration FDA approval to market its...
- Research articles 2002-07-21
- Lighting device to treat skin cancer.(Medical)
- Toin University of Yokohama and Ushio Inc have jointly developed a device to treat skin cancer by radiating light on a patient's skin, insiders claim. The device does not hurt patients like conventional surgical techniques. The university and the company have started leasing it...
- Research articles 2004-06-01
- Anderson's Abe: Key Skill for New Entrepreneurs is Managing Risk
- UCLA-Anderson's George Abe helps guide students through the labyrinth of details associated with creating new businesses. Last week, we discussed the language entrepreneurs needed to master to create great business plans and investor term sheets. In this post, we'll hear his ideas about venture risk and the current entrepreneurial...
- Blog posts 2009-06-17
- FUTURA MEDICAL (FUM).
- Futura Medical's niche business is developing over-the-counter OTC sexual dysfunction products. The first product ready for sale is likely to be condom safety device Zanifil, hopefully at the end of 2007, which will be distributed by Durex. Then, FLD500, a female lubrication condom, is expected...
- Research articles 2006-09-29
- How to Pass FDA Factory Inspections
- "Be prepared" is the best advice one can give. Those executives who have suffered an import ban following a factory inspection by the US Food and Drug Administration FDA know the value of this advice. Despite this obvious statement, many medical device companies do not spend enough time developing their...
- White papers 2004-07-26
- Aspect Medical Systems Business Update Call Transcript
- Question-and-Answer SessionOperator Thank you. Operator Instructions And we'll go to Tao Levy with Deutsche Bank. Tao Levy - Deutsche Bank Securities Hey, good morning. Nassib Chamoun Good morning, Tao. Tao Levy - Deutsche Bank Securities I'm having a few questions here. First, just maybe one a little bit quickly,...
- Earnings calls 2007-12-11
- Endologix Inc. Q4 2008 Earnings Call Transcript
- Question-and-Answer SessionOperator Operator Instructions John McDermott While we are waiting for the first question, I would like to announce that we will be presenting at the Lazard Capital Markets medical device conference being held March 25th and 26th in Snowbird, Utah. A webcast of this presentation will be available...
- Earnings calls 2009-02-19
- Boomers' sore knees, bad hearts drive investment
- SAN FRANCISCO -- Venture-capital investors, reflecting surging interest in Guidant and other medical-device companies, pumped $2.1 billion into that industry last year, the most since the venture financing boom of 2000, an industry survey out today shows. The MoneyTree Survey, which tracks venture-capital funding, is the second report showing...
- Research articles 2006-01-24
- BIOTRONIK Announces Start of Landmark 1,750 Patient Clinical Trial Evaluating the Complication Rates Associated with Implantable Device Replacement Surgeries
- LAKE OSWEGO, Ore. -- BIOTRONIK today announced that it has enrolled the first patient in the landmark REPLACE Registry, the first and largest prospective trial focusing on the complications associated with replacements and system upgrades of implantable pacemakers and defibrillators independent of the manufacturer. The first United States generator change...
- Research articles 2007-07-23
- Failing to Report Adverse Effects of Treatments
- We have frequently advocated the evidence-based medicine EBM approach to improve the care of individual patients, and to improve health care quality at a reasonable cost for populations. Evidence-based medicine is not just medicine based on some sort of evidence. As Dr David Sackett, and colleagues wrote [Sackett DL, Rosenberg...
- News items 2009-10-28
- Bush Administration Rule Stops Rape Victims Getting Plan B "Morning After" Pill
- A federal rule set to go into affect Jan. 18 will allow doctors and hospitals to withhold the Plan B "morning after" pill from rape victims if they so choose. The rule is designed to protect medical staff whose religious beliefs put even theoretical foetuses ahead of the needs of...
- Blog posts 2008-12-22
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