Category Archives: Latest

01Feb/17
FDA_small

Hear Directly from FDA: Driving a Culture of Quality for Devicemakers

Webinar Announcement

FDA and Industry Find Common Ground Driving a Culture of Quality

DATE: March 1, 2017
TIME: 1:30PM Eastern

Industry leaders and regulators are working on the Case for Quality (CfQ) initiative to shift their focus from compliance to quality by giving greater focus and emphasis to critical-to-quality practices throughout the lifecycle of the product.

Would you like to reduce your regulatory burden? Pay dividends in enhanced and predictable product performance? Streamline processes resulting in operational efficiencies? Reduce waste driving to lower costs and improved profitability?

CFQ_Webinar1

Join Sean Boyd — Deputy Director for Regulatory Affairs, CDRH’s Office of Compliance — Francisco (Cisco) Vicenty — Program Manager (Acting), Case for Quality, FDA — and Daniel R. Matlis — President, Axendia — on March 1st when they’ll discuss the effect the CfQ will have on med-tech manufacturers, healthcare providers, regulators and ultimately the patient.

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25Jan/17
wakup call

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
WP2 Main Image Strategic Leadership

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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