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Tag: quality system

Medical Device Quality System with UDI: Step-by-Step Guide | Operon Strategist

Medical Devices
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CAPA – Corrective Action and Preventative Action

Medical Devices
Posted by Rob Packard on July 18, 2023 What is a CAPA? How do you evaluate the need to open a new...

Audit schedule and an audit agenda, what’s the difference?

Medical Devices
Posted by Rob Packard on July 5, 2023 Internal audit and supplier audit programs both require an audit schedule and an audit...

15 Questions to Ask QMS Software Vendors in the Medical Device Industry

Medical Devices
As a medical device company, you are expected to deliver innovative, life-changing medical device(s) while ensuring compliance and achieving true quality. This task bears...

15 Reasons Why Medical Device Companies Choose Greenlight Guru

Medical Devices
MedTech companies are not just companies—they’re innovators building the medical devices that are saving and improving our quality of life.  But, bringing life-changing medical...

FDA issues warning to iRhythm over multiple violations

Medical Devices
<!----> The US Food and Drug Administration (FDA) has issued a warning letter to iRhythm Technologies over regulatory...

What is the design control process and how has it changed?

Medical Devices
Posted by Rob Packard on May 16, 2023 The design control process was copied by the FDA from Health Canada and ISO...

FDA US Agent – What do they do?

Medical Devices
Posted by Rob Packard on May 9, 2023 Medical device companies exporting devices into the USA must have a US agent to...

FDA US Agent – What do they do?

Medical Devices
Posted by Rob Packard on May 9, 2023 Medical device companies exporting devices into the USA must have a US agent to...

Incoming Inspection – How to perform a single process audit

Medical Devices
Posted by Rob Packard on May 3, 2023 The incoming inspection process is my favorite process to audit, and it is the...

Precision: Driving Success in Life Science through Calibration & Metrology

Biotechnology
Metrology is critical to any life science manufacturing process in a highly technical and regulated industry. At PSC Biotech,...

Nine easy ways to organize and improve quality system procedures

Medical Devices
Posted by Rob Packard on March 28, 2023 Would you like to learn nine ways to improve your quality system procedures? One...
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