Category Archives: Business

24Feb/17
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Data Integrity White Paper Alert

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TURN YOUR DATA INTO KNOWLEDGE

Sound data is the foundation to good decisions and good science.  In the Life-Science industry patient outcomes, product quality, safety and efficacy all rely upon vast amounts of data that is generated throughout the product lifecycle.  This means that patients, brand equity and reputations have the potential to suffer greatly without a strong data integrity foundation.

What is Data Integrity?

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25Jan/17
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Rapid Regulatory Changes Will Impact Medical Devices and Diagnostics Industry

By: Hugo Felix, Director Design Quality Assurance, Bard Access Systems

This is Your Wake Up Call!

The Medical Device and Diagnostics Industry is experiencing rapid regulatory changes.  To deal with these changes there are certain key areas that need to be addressed so we can thrive, rather than just survive.  Quality Systems need to account for that, deal with the rapid pace and help us manage it.

New standards, regulations and guidances will have a significant impact in our industry:

  • The International Organization for Standardization (ISO) published ISO 13485:2016.  This represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices
  • ISO 13485:2016 has a 3 year transition period and no new accreditations to the 2003 version after year 2
  • TC210 just approved changes to ISO 14971, Application of Risk Management to Medical Devices and an update to the accompanying ISO TR 24971 and a new TR for Post Market Surveillance

For its part, the US FDA issued guidances late last year on Benefit Risk Analysis for Pre and Post Market and draft guidances for deciding when to submit a 510K for device changes and another for software changes. MDD/IVDD to MDR/IVDR change is slated for May 2017 with full implementation deadlines of 2020 for MDR and 2022 for IVDR.

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06Jan/17
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Industry Executives Discuss Change in a Complex Environment

By: Sandra K. Rodriguez, Market Analyst

Life Science Industry Executive Roundtable – Event Brief

ert-picComplex – the one word that accurately describes the current environment in Life-Sciences. As products and manufacturing processes become more complex, managing change comes with a higher level of risk.  To discuss the importance of managing change in this complex environment, as well as examine key findings from our latest research on Change and Configuration Management, Axendia brought together a select group of executives from leading Life Science companies for a roundtable in Princeton, NJ.

A primary thread of the discussion was the need for closed-loop Change and Configuration Management (C&CM) strategies.  Closing the loop is becoming critical to ensuring product quality throughout the product lifecycle.

The research shows that:

  • 63% of survey respondents say their C&CM process is only somewhat effective or useless
  • Not a single respondent reported they have an idealC&CM system in place
  • 55%report that a slow and cumbersome C&CM process keeps them up at night
  • 62% rateregulatory and government agencies as their TOP business disruptor

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11Oct/16
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Does Having a Closed Loop Process Really Matter to Your Business?

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

Recalls are on the rise. How can you avoid them?

Analysis shows a 97% increase in the annual number of medical device recalls for the 10-year period, increasing from 604 recalls in FY 2003 to 1,190 recalls in FY 2012. 

Want to learn how a Closed Loop Process can prevent recalls, drive accelerated innovation, improve product quality and enhance company performance?  Does Having a Closed Loop Process Really Matter?

Download the white paper to find out how Med-Tech Innovators are avoiding recalls by implementing closed loop change and configuration management processes.

Contact: research@axendia.com to see if you qualify for a complimentary access code and save $499.