FDA Law Blog

NOVEMBER 29, 2023

Transparency This guiding principle calls for manufacturers to be transparent with users regarding the device performance before and after the implementation of the change. The 510(k) summaries also include details on the planned modification protocols, including an impact assessment to address requirements for data management.

Drafting 115

Drafting Data Management Manufacturing Healthcare 115

FDA Law Blog

JANUARY 5, 2023

The Playbook is a guide for healthcare delivery organizations to respond to cybersecurity incidents that threaten device function and, potentially, patient safety. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well.

Calendaring 59

Calendaring Healthcare Manufacturing Data Management 59

The Process Street

JANUARY 1, 2024

These solutions may incorporate elements of quality management as part of broader regulatory compliance frameworks, particularly in highly regulated industries like pharmaceuticals and healthcare. Qualityze aims to facilitate compliance with quality standards such as ISO 9001, FDA regulations, and other industry-specific requirements.

Document Review 52

Document Review Document Management Manufacturing Healthcare 52