Sumatha KondaboluBlog category
Medical Devices
Articles on Medical Devices from the Qualio blog.
Sumatha KondaboluThe 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.
Medical Devices
Lindsay Orem
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!
Medical Devices
Robert Fenton
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.
Medical Devices
Meg Sinclair
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.
Medical Devices
Meg Sinclair
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.
Medical Devices
Kelly Stanton
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.
Medical Devices
Meg Sinclair
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.
Medical Devices
Jodi Hutchins
What you need to know about medical device validation
Medical device validation determines whether you built the right product for its intended use. Learn the benefits and key steps of medical device validation.
Medical Devices
Meg Sinclair
Medical device quality management system template: 8 powerful options
With the right medical device quality management system template, you can quickly produce a market-leading device. Use these 8 templates to get started.
Medical Devices