• There are no suggestions because the search field is empty.

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

Case Study: Digiteyez Technologies

Digiteyez Technologies uses Sierra QMS to streamline compliance processes and tackle FDA regulations for their medical device, Clear.
Read more

Case Study: Transparency Life Sciences

How Sierra Labs and TLS Partnered to Streamline Their Quality Process
Read more

Pro Tips Surrounding Design Controls for Medical Devices

Breaking Down Design Control Requirements for Medical Device Development Teams
Read more

The Ultimate Quality Management System for Life Sciences

Must-Have Features & Functionality for Your Quality Management System (QMS)
Read more

How to Create Successful SOPs for your Medical Device

Explore the key considerations for Standard Operating Procedures (SOPs) for Medical Device Companies
Read more

What are Standard Operating Procedures (SOPs)?

Defining SOP’s as they pertain to your Medical Device.
Read more

What is FDA's 21 CFR Part 820?

Unpacking the FDA guidelines and regulations under 21 CFR Part 820.
Read more

A Regulatory Approach Manual for Device Software Functions

Understanding the policies for your Medical Device Software Functions
Read more

Recent Posts

Topics

See all

Subscribe Here