Sierra Labs Blog

By: Sierra Labs on 10/28/20 10:48

Learn how to stay compliant with FDA's Part 11 in the age of automation!

By: Sierra Labs on 07/29/20 9:12

Uncovering how Agile practices fulfill Software as a Medical Device (SaMD) Development

By: Sierra Labs on 07/16/20 12:57

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

By: Sierra Labs on 07/02/20 11:56

Easy ways to meet FDA Regulatory Requirements with your Software Development Plan

By: Sierra Labs on 05/28/20 11:02

Outlining the Preliminary Qualifications and Evaluation of FDA’s Updated RTA Policy for 510(k) Submissions

By: Sierra Labs on 04/30/20 8:47

Learn how your company can form a Regulatory Strategy in 8 easy steps.

By: Sierra Labs on 04/16/20 9:07

Uncover which regulatory pathway is right for your medical device!

By: Sierra Labs on 04/09/20 11:48

How to utilize ISO 13485 to acquire a CE Marking on your Medical Device.

By: Sierra Labs on 03/16/20 12:40

Step by step instructions on navigating your Corrective Action & Preventive Action (CAPA) for FDA.

By: Sierra Labs on 02/12/20 10:58

A simple guide to conquering your Pre-Submission Meeting with FDA, plus some free tools!