What Actually Happens in a Pre-Submission Meeting with FDA? Part I
Understanding the power of utilizing a pre-submission for your medical device.
Read more
FDA Releases Guidance On Cybersecurity for Medical Devices
Why Cybersecurity is crucial in the Medical Device & SaMD Industry
Read more
Why Sierra QMS is the Right System for Your Startup
How QMS is a crucial part of regulatory compliance for Medical Device Startups!
Read more
Why an Interactive eQMS Free Trial is Imperative to your Company’s Success
Four main areas of an eQMS your organization should test before purchasing!
Read more
Vital Benefits of a Highly Customizable and Scalable eQMS
Why it is imperative to incorporate a wide range of regulatory compliance tasks into one comprehensive platform.
Read more
Guide to HIPAA Compliance: Achieving & Maintaining Data Security
Step by step guide for obtaining HIPAA Compliance for your Healthcare or Life Science organization.
Read more
5 Easy Steps for SaMD Startups to Successfully Implement a QMS
Learn about setting up a QMS for Software as a Medical Device (SaMD), from planning, documentation, implementation, to control.
Read more
Architecting Atlassian for Healthcare and FDA Compliance: Part 1
Bridging the gap between agile development for innovation and audit readiness for compliance!
Read more
Architecting Atlassian for Healthcare and FDA Compliance: Part 2
Using Atlassian’s Jira framework to transform and boost DevOps!
Read more
Case Study: Digiteyez Technologies
Digiteyez Technologies uses Sierra QMS to streamline compliance processes and tackle FDA regulations for their medical device, Clear.
Read more