medical device quality

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Published By: SAS     Published Date: Aug 06, 2019
With the combination of electronic health records, rich repositories of claims data, medical device outputs, laboratory and prescription systems, real-world data and the data mined from other information technology systems, the health and life sciences ecosystem can now gain new perspective. Download this complimentary paper to learn more about how health care data has the power to transform the sector, helping to address the industry’s biggest challenges surrounding costs and quality of patient care. By adopting solutions that allow them to both produce and consume data analytics insights in a way that better guides clinical and business strategies, innovative health care organizations can learn not only to survive but also thrive in the decades to come.
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SAS
Published By: SAS     Published Date: Aug 19, 2019
With the combination of electronic health records, rich repositories of claims data, medical device outputs, laboratory and prescription systems, real-world data and the data mined from other information technology systems, the health and life sciences ecosystem can now gain new perspective. Download this complimentary paper to learn more about how health care data has the power to transform the sector, helping to address the industry’s biggest challenges surrounding costs and quality of patient care. By adopting solutions that allow them to both produce and consume data analytics insights in a way that better guides clinical and business strategies, innovative health care organizations can learn not only to survive but also thrive in the decades to come.
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SAS
Published By: UPS     Published Date: Sep 05, 2017
Our active and actively aging population is the dichotomy fueling significant growth for implantable medical devices. Innovations focused on mobility, engagement and quality of life are directly targeting this growing population. The implantable medical device industry is poised to capitalize on these unique needs, while simultaneously meeting unprecedented cost pressures. It is time for manufacturers to seek expertise in inventory management and logistics for greater visibility, control and profitability. For implantable medical device manufacturers to be as active and healthy as the patients they serve, their future depends on the ability to differentiate products — not only by price, but through cost, service and documented outcomes. New trends in personal health tracking keep patients moving, and data collection will similarly improve the health of your business.
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medical devices, inventory management, logistics, clinical outcomes data, ups
    
UPS
Published By: UL EduNeering     Published Date: Jul 05, 2012
This paper summarizes the results of a quantitative benchmarking survey to over 200 Life Science organizations. The study identifies the key compliance and performance improvement training topics they had addressed in 2011 along with key issues for 2012.
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fda, gmp, gcp, gxp, cms, osha, qsr, 21 cfr part 11
    
UL EduNeering
Published By: UL EduNeering     Published Date: Jul 05, 2012
Good Manufacturing Practices (GMP) violations have become the new healthcare fraud as the Department of Justice (DOJ) tests out new legal theories under the False Claims Act (FCA). The Food and Drug Administration (FDA) has dusted off its regulatory authority to prosecute GMP violations.
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fda, gmp, gcp, gxp, cms, osha, qsr, 21 cfr part 11
    
UL EduNeering
Published By: UL EduNeering     Published Date: Jul 05, 2012
Cost reduction is a key criteria that executives often use when choosing initiatives to focus on. They are the ones that have the greatest potential to impact an organization's bottom line. Across life science organizations, a critical area for cost containment is training management.
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fda, gmp, gcp, gxp, cms, osha, qsr, 21 cfr part 11
    
UL EduNeering
Published By: ETQ     Published Date: Jul 10, 2019
The FDA has announced plans to transition to standard ISO 13485:2016 for medical devices in 2019. In addition, the Medical Device Single Audit Program, MDSAP, has gained traction with full implementation set for 2019. Download this paper to learn more about these two changes from the U.S. Food and Drug Administration’s proposal to harmonize and modernize its Quality System Regulation (QSR).
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ETQ
Published By: UL EduNeering     Published Date: Jul 05, 2012
SOPs are critical to efficient manufacturing operations, quality control, and regulatory compliance. This paper reviews best practices for the Life Science industry for training on SOPs, and how learning management technology has the potential to improve learner retention through automated assessments.
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fda, gmp, gcp, gxp, cms, osha, qsr, 21 cfr part 11
    
UL EduNeering
Published By: UL EduNeering     Published Date: Jul 05, 2012
Third party intermediaries have played starring roles in some of the most highly publicized global corruption trials. By any measure, third party intermediaries routinely rank high on the list of compliance worries for brand companies.
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fda, gmp, gcp, gxp, cms, osha, qsr, 21 cfr part 11
    
UL EduNeering
Published By: IBM     Published Date: Mar 04, 2015
Medical Device companies have typically shied away from design reuse because of the fear of a single point of failure. However due to market pressures, more and more medical device companies must embrace reuse to increase time to market. Unlike common perception, strategic and effective reuse can actually benefit regulated industries like medical devices by expediting compliance. This webcast will discuss the benefits of reuse as well as concepts of continuous engineering that can improve quality for medical devices.
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design reuse, reuse, continuous engineering, medical device quality, compliance regulations
    
IBM
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