Copy of Understanding Continuous Improvement in Quality Management

In this Issue

From the Editor ????| In-Brief?? |?Featured ???| Sections ? | Postscript ??

From the Editor????

In case you missed it, check out 6 Tips on Writing Excellent Procedure by EU MDR Compliance

?? Plus, 12 other super-useful new posts and Martin King's Regulatory Roundup.

In Brief ??

Featured Post

The importance of continuous improvement in quality management, outlined by Harsh Thakkar?

• ISO - International Organization for Standardization outlined how quality assurance is the driving force to organizational success
• Tibor Zechmeister posted a new video on Ensuring the Safety of Clinical Investigations Under Article 71 of the MDR
• EU MDR Compliance underscored the difference between FMEA and ISO 14971
• The latest revisions to MDCG 2021-5 Rev 1 were shared in a useful guide by Med-Di-Dia Limited?
• Boris Gurevich detailed an FDA report on non-device software and their risks
• Vijay Anger underlined a US medical image analysis software market size and trends?
• A breakdown of the key updates to ISO 14155 was posted by Dr. Sathesh Kumar Annamalai?
• Augusto Geyer announced a new publishment amending RDC 591/2021
• The key applications of NGS-based IVDs, overviewed by CMG MedDev
• Stefano Bolletta shared: Regulatory changes for software-based medical devices Version 1.3, June 2024, from TGA AUSTRALIA

Featured Podcast ???

Are you AI savvy? Get up-to-speed fast with this new podcast, “The Good Bot: Artificial Intelligence, Health Care, and the Law,” shared by Brett Mason

Featured Webinar

Sections ?

Featured Post ??

Understanding Continuous Improvement in Quality Management

Special thanks to Harsh Thakkar for sharing his hard-won insight:

True quality management isn’t about perfection; it’s about continuous improvement.

To achieve excellence in your organization, commit to ongoing enhancements, he suggests:

• Highest quality products: Continuously gather and act on customer feedback.
• Efficient processes: Regularly identify and eliminate inefficiencies.
• Informed decisions: Base actions on accurate and relevant data.
• Culture of improvement: Engage all employees and value their contributions.
• Lasting success: Balance small, incremental changes with breakthrough innovations.

Continuous improvement is about constantly striving for better—every single day—rather than reaching a final destination.

? Weekly Regulatory Roundup

By Martin King, July 1, 2024

In This Week's Regulatory Roundup

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Postscript ??

Meet me in Malaga!

Registration is now open for TEAM-PRRC THIRD ANNUAL SUMMIT: 2024, October 17 & 18; Malaga (Spain).

I will be there, will you?