3Analytics Partners With AssurX to Revolutionize IMDRF Coding Using AI
The IMDRF Coding solution integrates seamlessly into AssurX EQMS, ensuring comp [...]
10
03, 2025
18
12, 2024
Overcoming the Challenges of Medical Device Complaint Handling with AI: How 3Analytics Leads the Way
The medical device industry plays a pivotal role in global healthcare, deliveri [...]
21
11, 2024
FDA Inspection Expectations in 2025
The U.S. Food and Drug Administration (FDA) has been ramping up on-site inspect [...]
30
10, 2024
Preparing for ISO 13485 Harmonization: Where Do Things Stand Today?
In January 2024, the U.S. Food and Drug Administration (FDA) issued a final rul [...]
24
10, 2024
5 Places to Use a FMEA in Your Quality Process
Before any road trip, it makes sense to check your tire pressure along with lev [...]
13
06, 2024
Customer Quality Management: How the QMS Can Help
Customer complaints are a fact of life in any industry. Even though manufacture [...]
30
01, 2024
The Hidden ROI of Complaint Management
Formal complaint management is a requirement in regulated industries such as med [...]
30
05, 2023
Complaint Management for Life Sciences with an Automated QMS
Effective complaint handling is fundamental to life sciences quality management [...]
20
04, 2022
Understanding FDA Alignment of ISO 13485 with Quality System Regulation
The FDA’s official proposal to align its Quality System Regulation (QSR) with IS [...]
31
03, 2022
miraDry Implements AssurX Quality Management and Regulatory Compliance Software
MORGAN HILL, CA, UNITED STATES, March 31, 2022 – AssurX, Inc. (AssurX), a leader [...]
