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.
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 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.
A comprehensive guide to ISO 14971: Risk management for medical devices
Learn everything you need to know about ISO 14971, risk management for medical devices, and how to implement it into your quality management system.
A practical guide to implementing Risk Management for medical device startups
Follow this step-by-step approach to implementing risk management in your medical device startup and review what's essential in effective risk management.
How SaMD companies can use a QMS to improve regulatory compliance
Without understanding regulatory expectations for software as a medical device (SaMD), an SaMD company may fail to meet FDA requirements. Learn how a QMS can help.
The 4 Best Medical Device Quality Assurance Training Options
Medical device quality assurance training can give your team the knowledge and confidence to move your company to the top of your industry.