Category Archives: Regulatory

27Sep/16
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Don’t Solve Quality Problems, Avoid Them

New White Paper: The Future of Change and Configuration Management in the Med-Tech Industry

Can you distribute poor quality products while complying with all applicable regulatory requirements? Sure! After all, you can conduct a recall of poor quality products in compliance with all applicable regulations.  FDA’s Top Medical Device official agrees.

Jeff Shuren, M.D., J.D., Director of FDA’s Center for Devices and Radiological Health (CDRH), put it this way: “…one device manufacturer can meet FDA requirements and still make a poor quality device; whereas, a second manufacturer may not comply with all FDA requirements and yet make a high-quality device.”

Is your organization focused on Solving Quality Problems or Avoiding Them?  Download the white paper to find out how Med-Tech Innovators have been able to shift their focus on improving market presence, manufacturing processes and product quality.

Contact: research@axendia.com to see if you qualify for a complimentary access code and save $499.
21Sep/16
Data Integrity in LS

Data Integrity – A Requirement for FDA Compliance, Quality and Beyond

On Demand Webinar Announced

Data integrity and quality are foundational for regulatory compliance and good science, an issue that was recently highlighted by the new “FDA Guidance for Data Integrity and Compliance with cGMP”. This guidance was issued to address a growing number of data integrity violations and underscores the importance of data quality and integrity to support intellectual property protection and patient filings in regulated and non-regulated spaces.

DownloadData Integrity in Life Sciences a PDF of this inforgraphic.

We discuss what Goldilocks and Life-Sciences companies have in common during the webinar. An on demand recording is available here.

05Aug/16
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Medtech Strives to Get a Handle on 3D Printing

By: David R. Somers, Senior Industry Analyst

The Industry and FDA Explore 3D Printing Applications for Medical Devices

Not since the development of electron beam (e-beam) evaporation and thin layer epitaxy for silicon wafer manufacturing has the industry of small-scale (down to the nano-substrate level) applied technology been so exciting for the development of products that, until now, were very difficult to even produce, much less improve. The technology I refer to is that of 3D printing.

The FDA is seeking to understand the applicability of 3D printing for medical devices. Their recent offering on July 14th made a presentation through a Grand Round webcast as part of a larger program sponsored by the U.S. Navy and FDA to present a frame of reference and thinking behind the effects of such technology within the context of medical devices.

Continue reading the full article in Medical Product Outsourcing.

18Jul/16
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Next Steps in FDA’s Global Transformation

By: Ellyn McMullin, Research Associate

The Agency Continues to Take Measures to Ensure the Safety and Quality of Imported Medical Devices

Five years ago FDA unveiled its new global strategy to help ensure safety and quality of imported products in an increasingly complex global supply chain. According to the agency, in 2011 half of all medical devices used in the United States were imported, while 80% of the active pharmaceutical ingredients in medications sold here were manufactured elsewhere. It was optimistically estimated that imports of FDA-regulated products would triple between 2007 and 2015; of course, with the severe recession, the results did not quite reach that projection. However, the increase in imports was still significant.

A key component of the FDA’s new approach (as detailed in a special report “Pathway to Global Product Safety and Quality”) was to partner with its counterparts worldwide to insure and improve global product safety and quality. As reported in 2014, the FDA had at that time more than 60 agreements with their counterparts to share some information in inspection reports.

Continue reading this article in MedTech Intelligence.

29Jun/16
quality

FDA and Quality Metrics in Biopharma

By: David R. Somers, Senior Industry Analyst

Moving Right Along 

The continuing efforts by biologic and pharmaceutical manufacturers to join the FDA in improving product quality, reducing inspection costs, increasing the effectiveness of product monitoring, and streamlining reporting requirements have crossed the Rubicon of mere theorizing, discussion, and contemplation into firm and proactive steps. Those efforts have been aimed at the establishment of acceptable and realistic standards of measurement for product development, testing, implementation, distribution, and monitoring. These activities are in concert with the broader effort by FDA to promote innovation, increase stakeholder involvement in quality, and enhance the safety of the supply chain.

To support this initiative, the International Society for Pharmaceutical Engineering (ISPE) created a cohesive, comprehensive series of criteria for the measurement of critical parameters needed to define and control quality in biologic and pharmaceutical manufacturing.  Subsequently, using many of the metrics developed by the ISPE, the FDA submitted a draft guidance document called Request for Quality Metrics.

Continue reading the full article in Outsourced Pharma.