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Don’t Make the Mistake of Having Separation between Your ERP (Enterprise Resource Planning) and your QMS (Quality Management System)
3/15/2013
Regulatory compliance in the medical device industry is serious business. At stake are patient safety, doctor and company reputations, and the potential for large fines and negative publicity if something goes wrong due...
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The Business Case for Materials Information Management in Medical Device Design
3/15/2013
Less risk of product recalls, faster time-to-market, greater R&D productivity, and improved regulatory submissions
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Three Key Areas to Reduce Costs with Lean Techniques
3/1/2013
While the principles behind lean techniques can be applied to nearly any business, the term “lean” is most often associated with process improvement and cost reduction in manufacturing. Most businesses ascribe to the...
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The Role of the LMS in 21 CFR Part 11 Compliance
8/31/2012
The purpose of this white paper is to describe how NetDimensions Learning addresses the technical requirements of the U.S. Food and Drug Administration’s 21 CFR Part 11 Electronic Records; Electronic Signatures. This...
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Life Sciences Guidebook: Best Practices for Selecting & Implementing FDA Compliance Software Solutions
8/7/2012
As the world market evolves, product lifecycles are speeding up to accommodate market demand and keep up with competing products. As a result, Quality benchmarks need to evolve as well. Risk is fast becoming the...
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Performance Diagnosis And Training The Human Hand With Sensor Technology
5/23/2012
With the HFD200 hand and finger dynamometer, the doctor has available a diagnosis and rehabilitation system for the human hand, which measures the forces used to bend and stretch the hand and the individual fingers,...
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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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Clear SOUP and COTS Software for Medical Device Development
10/4/2011
In many industries, manufacturers have reduced development times by using COTS (commercial-off-the-shelf) software and hardware in their products. Pressures to bring new, feature-rich products to ...
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Choosing an RTOS for Remote-care Medical Devices
10/4/2011
Three trends are driving a dramatic increase in the number and diversity of remote-care medical devices entering the market: aging populations in industrialized countries, pressures on private and...
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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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Software Development for Medical Devices: Overcoming the Challenges of Compliance, Quality and Cost
9/9/2011
Software is fast becoming the differentiator for manufacturers of medical devices. The rewards available from software innovation are balanced by the risks and challenges of regulation, stringent quality requirements,...
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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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Quantifying the Business Value of Medical Device Connectivity
7/27/2011
Each Connected Medical Device (CMD) saves from 4 to 36 minutes of nursing time and prevents up to 24 data errors daily. CMDs can save over 100 hours of nursing time per day in a typical hospital, giving nurses more time...
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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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Medical Device Quality Systems Demystified: Why Companies Need Best-of-Breed ERP, PLM and EQMS
3/17/2011
Intense global pressures, such as more stringent regulatory scrutiny, tax increases and reimbursement challenges are causing stalled top-line growth for medical device organizations and prompting them to find ways to...
