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Electronic Reporting: What You Need to Know to Comply with eMDR
12/13/2011
eMDR, electronic medical device reporting, is an efficient method of submitting vigilance reports to the Center for Devices and Radiological Health (CDRH) at the FDA. Top medical device manufacturers, distributors, and...
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Beyond Compliance: How PLM Supports a Successful TPLC Deployment
10/11/2011
Despite a global recession, medical device manufacturers are facing an unprecedented growth opportunity. High consumer expectations for better healthcare and technology advances that improve quality of life are creating...
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Choosing and Implementing an ERP Solution as the Core of a Quality System: Medical Device Manufacturers Share their Advice
10/6/2011
White Paper Summary Choosing and implementing an ERP system is not a trivial task—especially for medical device manufacturers. Because it plays a central role in an overall quality system that must be validated...
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Persistent Publish/Subscribe Messaging in Medical Devices
10/4/2011
Many medical devices must bring together a disparate array of hardware and software components, as well as support a sophisticated, multi-layered Human- Machine Interface (HMI). Persistent Publish/Subscribe (PPS)...
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An Insider's Guide to Selecting a Quality Management Software System
9/2/2011
As demand for Quality Management solutions grow, so does the vendor landscape - more software vendors are providing solutions for Quality and Compliance Management than ever before. With a high demand and a large vendor...
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Enhancing Collaboration with the FDA through MedWatch Plus
9/2/2011
The Food and Drug Administration (FDA) is tasked with the job of ensuring that all products produced within medical device, food and beverage, pharmaceuticals, biologics, and all other industries are produced safely and...
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Keeping up with the New Pace of Business: How Risk Management Tools can Improve Product Quality in Today’s Rapid Lifecycles
9/2/2011
With the product lifecycle moving so fast, many organizations may ask the question, "how can we effectively measure quality?" What can an organization do to keep up with this new pace of business while...
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Managing your Risk Has its Rewards: Making the Case for Risk Assessment in Streamlining your Quality and Compliance Processes
9/2/2011
In today's Quality Management systems, the ability to control and correct processes is key to maintaining a high level of compliance within an organization, and in many cases, the ability to discern the overall...
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Enabling 21 CFR Part 11 Compliance
4/5/2011
The Food and Drug Administration’s Code of Federal Regulations Title 21 Part 11 (FDA 21 CFR Part 11) helps streamline compliance with a wide range of FDA regulations by supporting FDA regulated industries in their...
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A Holistic Approach to Product Introduction and Change Processes
2/25/2011
The world's leading medical device companies are focused on delivering new products that improve patient outcomes and enable the medical community to deliver the best possible patient care. In today's...
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Enterprise Level Change Control: A Life Sciences Business Imperative
7/16/2010
Drug and medical-device manufacturers spend hundreds of millions of dollars to gain regulatory approval for their new therapies and therefore require significant returns just to break even. Add to that the strict...
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Addressing the Challenges of Complaint Handling, Investigations, and Adverse Event Reporting
7/16/2010
Quality is an ever-growing problem in the fi elds of pharmaceutical, medical devices, medical diagnostics and biologics, and its negative impact is signifi cantly palpable to manufacturers as well as their patients,...
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Issues Facing Device Manufacturers as FDA Moves Closer to Mandating Electronic Reporting (eMDR)
4/6/2010
In the coming months, FDA's Center for Device and Radiological Health (CDRH) is rumored to be issuing a rule that will establish a timetable for requiring electronic submission of Medical Device Reports (eMDRs). When...
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The Manufacturer’s Lament: The Right Solution to the Compliance Challenge
Exact Software North America LLC
4/1/2010
For many manufacturers, the journey to achieve and maintain regulatory compliance is long and arduous. An ever-evolving business climate adds complexity as well. The trip is filled with challenges and doesn’t end at a...
