Medical Devices
8 best ISO 13485 training programs in 2024
Searching for the best ISO 13485 training? These top ISO 13485 training programs will help you improve quality processes at your medical device company.
How Much Is the FDA Medical Device Registration Fee in 2024?
The FDA medical device user fee for 2022 is $5,672. However, there are other fees medical device manufacturers should be aware of in 2022 and beyond.
The TGA's essential principles explained
Looking to get your medical device into Australia? Learn about the Therapeutic Goods Administration's 'essential principles' and how to embed them.
The complete guide to passing ISO 13485 audits
Learn how to prepare for and pass ISO 13485 audits. Get top tips to ensure your medical device company meets all requirements for passing an ISO 13485 audit.
Top 6 conferences in Australia for life science companies in 2023
Australia is a vibrant and emerging life science market. Keep your finger on the pulse with our pick of the 6 key industry conferences to be at in 2023!
ISO 13485 vs. ISO 9001: understanding the key differences for medical devices
Discover the key differences in scope, significance and application between the ISO 13485 and ISO 9001 quality standards for medical devices.
The 6 most common triggers for FDA 21 CFR 820 non-compliance in 2022
Where are US medical device companies going wrong with their 21 CFR 820 compliance? Form 483 inspectional observations reveal the most common non-conformance triggers.
The 4 best ISO 13485 audit checklists
These 4 free ISO 13485 audit checklists will help you achieve ISO 13485 compliance, prepare for certification and pass an audit.
What is a bill of materials? A guide for medical devices
A bill of materials is a list of components needed to manufacture your medical device. Learn why you need a BOM, how to create one and different BOM types.
Everything you need to know about Design History Files (DHF)
Learn what a Design History File is and why it's important, the contents of a DHF, and how to prepare your DHF for an FDA Audit.