How to Meet Regulatory Expectations for SaMD
Leveraging these expectations to ensure the highest level of quality for your Software as a Medical Device (SaMD)
Read more
Top 3 Requirements for Software as Medical Device (SaMD)
A deeper dive into crucial policies for Software for Medical Device (SaMD) Organizations
Read more
Crucial Do’s and Don’ts of SaMD Development
Explore the unique challenges and considerations of SaMD development.
Read more
FDA's Quality Management System Regulation Revised (QMSR) for Medical Devices
Simple Guide to FDA’s harmonization of 21 CFR part 820 with ISO 13485:2016
Read more
The Secret to a Successful Hardware Development Process
What is the right approach to developing hardware-based medical devices?
Read more
What are CAPAs?
Learn the purpose of Corrective and Preventive Actions (CAPAs) for Medical Device Development.
Read more
What is FDA's 21 CFR Part 820?
Unpacking the FDA guidelines and regulations under 21 CFR Part 820.
Read more
3 Crucial Steps in Choosing the Right GxP Cloud Provider
What should be on your radar while tackling GxP Cloud Validation.
Read more
What is ISO 13485:2016?
An easily digestible overview of ISO 13485 and how it applies to your medical device company.
Read more
ISO 13485 vs. CFR Part 820
A comparative study on the key differences between FDA’s QSR and ISO’s QMS.
Read more