Security Analytics: Tools of the Trade
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As attackers have learned to evade traditional signature-based solutions such as firewalls and anti-virus software, an analytics-based approach has become extremely important.
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ISO 13485: Change? Do I Have To?
Risk is mentioned some 15 times throughout the standard, to account for the specific issues being addressed. Risk is to be considered in outsourcing and supplier controls, with respect to software validations, and in the training of personnel commensur…
Smooth Transition! Get Tips for a Simplified ISO 13485 Transition
This video, which is the third part in a three-part series, will answer the following questions:How should we transition to ISO 13485:2016? Should we consider the various device types? As of March 2016, we have three years to implement the new standard…
MasterControl Registrations for Medical Device
For medical device firms, the process is part of an intense period of obtaining a 510(k) clearance or a PreMarket Approval (PMA) in the United States. While the information required is essentially the same for various registrations, the preparation, pr…
What, When, Why, How? Adjusting to the ISO 13485:2016 Standard
In this video, Walt Murray, quality and regulatory consultant, addresses the following questions regarding ISO 13485:2016 readiness: Did ISO 13485:2016 adopt new elements into the revision of the standard based around the convention of the 9001:2015 st…
Top 5 Trends in the Medical Device Industry in 2017
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Amid all this uncertainty, however, the outlook for medical devices is surprisingly bright. Investing News predicts that device manufacturers will capture major market share in 2017. Equally reassuring, Evaluate Research forecasts that medical technology sales will reach more than $529.8 billion by 2022, growing at an annual rate of 5.2 percent, and R&D expenditure will grow by 4.3 percent annually to reach $34 billion by 2022.
In this white paper, medical device experts Matt Lowe and Alex Butler discussed five trends that are likely to have a significant effect on the industry this year. |
FDA Readiness Toolkit for Medical Device Companies
The guidelines set forth by the FDA are a major factor in ensuring that companies manufacture and sell medical devices that are safe, reliable, and effective. Whether they do it effectively or not, complying with these regulatory guidelines is simply a…
FDA Readiness Toolkit for Pharmaceutical Companies
The guidelines set forth by the FDA are a major factor in ensuring that pharmaceutical companies manufacture and sell products that are safe, reliable, and effective. Compliance with FDA regulations is simply just a part of doing business for pharmaceu…
Getting Ready! Applying the ISO 13485:2016 Standard
This video, which portrays the second part in a three-part series, will answer the following questions regarding the most recent version of ISO 13485: What are the high-level considerations of ISO 13485:2016? How should I present these to management?Ho…
5 Pharma Trends That Will Have the Biggest Impact in 2017
Santos-Serrao is a member of the Regulatory Affairs Professional Society (RAPS) and the Drug Information Association (DIA) and has nearly two decades of experience in the regulatory affairs and clinical areas of the pharmaceutical industry. Following h…
