How to build a complaint management system

Learn about the steps to take to create a complaint management system, and how to choose a complaint management software to automate complaint management.

Compliance

Sumatha KondaboluMay 30, 2024

CDSCO registration: how to bring your medical device to India

The CDSCO is the gatekeeper of one of the world's fastest-growing medical device markets: India. Learn how to get your medical device into the subcontinent.

Compliance

Molly CalveyMay 29, 2024

The ultimate guide to change control for life sciences companies

Change control is a key part of your QMS. Learn how to write your own change control procedure for a change control process that's compliant and comprehensive.

Compliance

Sumatha KondaboluMay 20, 2024

The complete guide to SaMD (software as a medical device)

Software as a medical device is software that helps diagnose, treat or manage disease. Review SaMD examples and regulations that govern SaMD development.

SaMD

Jerry AdatsiMay 15, 2024

How to Manage the Med Device Software Development Process in Your eQMS

Managing the medical device software development process is a big undertaking.

eQMS

Sumatha KondaboluMay 13, 2024

Navigating climate change: updates to ISO certification standards

It isn't just the climate that's changing. ISO's 2024 update brings climate change into the heart of your quality management system planning. Learn what's new.

ISO 9001

Sumatha KondaboluMay 8, 2024

What the FDA's MDDS guidance means for you

Things have changed since the FDA's Medical Device Data Systems (MDDS) Rule in 2011. The 2022 guidance changes how MDDS are defined and regulated in the medical world.

Medical Devices