Medical Devices
The 13 Essentials of a Quality Plan for Medical Device Companies
Crafting a quality plan for medical device companies is difficult, and it must contain these 13 essentials if you want to make sure you avoid...
14 medical device quality management system requirements for regulatory compliance
By understanding the medical device quality management system requirements for regulatory compliance, you'll be ready to help keep your company off...
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.