A Closer Look: Understanding Risk Management for Medical Device Manufacturers
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Completing risk management to ISO 14971 is nothing new for medical device manufacturers. During the past several years, there has been more of a global alignment within this industry. Specifically, both the FDA in the United States and the Medical Device Directive in the European Union have made risk management compliance for ISO 14971 a requirement. This requirement actually forces manufacturers to establish a formal process for dealing with risk management and focuses on how manufacturers can produce safer products.
But how does the Third Edition of IEC 60601-1 work with the ISO 1991 standard and what does it mean for the medical device industry? Read more. |
Free Download: A Status of Quality in Life Sciences _________________________________________________________
Every quarter, our team at PathWise issues a new survey polling 25,000 quality professionals in the life science industry. Covering issues from CAPA to Risk Management, our survey responses provide an inside look into how quality departments and budgets are allocated and how life science organizations are currently managing their quality systems.
As a special thank you to our valued readership, we've compiled our 2011 quality survey results into a downloadable report. We hope you find this information of benefit for your quality system management efforts into 2012 and beyond.
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FDA Announces 2012 Medical Device Priorities
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The FDA's Center for Devices & Radiological Health announces its strategic priorities for 2012, including final versions of all guidance documents, guidelines for acceptable clinical data from foreign countries, streamlining the recall process and creating a framework for post-market surveillance.
Read complete article. |
Just Launched: Draft Guidance for Pharma & Medical Device Makers' Use of Social Media
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The Food and Drug Administration recently published draft guidelines for pharmaceutical and medical device companies on the use of "emerging electronic media," A.K.A. social media marketing and communication.
Though the FDA notes the proposed guidelines aren't comprehensive and rather the "first of many planned guidance initiatives," the move marks the first time the FDA has clearly addressed rules for Pharma and medical device makers' digital communication via social media and other channels - even specifically mentioning services like Twitter, Facebook and YouTube.
Read complete article. |
Stay in the Quality Loop with "FDA Voice"
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Last month, the Food and Drug Administration launched its newest official blog called "FDA Voice". FDA Voice's first blog entry, authored by FDA Commissioner Margaret A. Hamburg, M.D., explained that the purpose of the blog is for senior FDA leadership and staff to explain topics about the work done at FDA that they think would be of interest to the American public.
Read complete article. |
Industry Survey: Use of employee titles preferred over names in investigation reports
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When conducting and documenting quality investigations, the inclusion of specific employee names is often up for debate. Last month, we issued a poll to over 25,000 quality professionals asking "Do you include employee names or employee titles in your investigation reports?"
Here are the results from the poll:
Employee Names: 26.1%
Employee Titles: 73.9%
Learn more best practices for conducting quality system investigations. |
Did you know?
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Since 1993, we've worked with the best in the life science and manufacturing industries and bring an intimate knowledge of regulatory and compliance standards.
This year we're rolling out new training and consulting programs on Change Control, Risk Management, Investigations and more. Get the scoop in our latest e-brochure.
Learn more about our solutions for quality system improvement. |
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Monthly Newsletter
PathWise, Inc.
January 2012 |
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Upcoming Events
CAPA for Life Sciences
These 2-day courses are designed to meet the requirements mandated by regulatory agencies to effectively investigate and locate causes and correct them.
Feb. 15-16, 2012
Switzerland
_________________ Audit Management
This 2-day course is designed to to train and prepare individuals to manage the quality audit process through reading, lecture, discussion, role playing, and practical exercises.
March 15-16, 2012
Chicago, IL
June 14-15, 2012
Boston, MA
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PathWise Webinars
Integrating FDA and Trending
Requirements into your CAPA System
This session offers attendees a how-to approach to effectively integrate the FDAs CAPA and trending requirements, providing them with the skills and tools necessary to develop a strong, sustainable and compliant CAPA System.
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Best Practices to Manage an FDA Inspection
When it comes to quality system audits, the level of preparation within your organization can make a significant difference in your level of success. This webinar discusses how to effectively prepare for and manage an FDA inspection.
Download webinars.
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