What Atlassian's Elimination of Jira Server Means For Your Business

How the transition from Jira Server to Jira Cloud will impact Healthcare and Life Science Companies
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A Simple Breakdown of ISO and IEC Standards for SaMD

Understanding the difference and benefits between ISO and IEC Standards for Software as a Medical Device
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5 Ways to Stay Compliant with 21 CFR Part 11

Learn how to stay compliant with FDA's Part 11 in the age of automation!
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The Ins and Outs of Hardware-Based Medical Device Production

The Pressures and Pain Points of Hardware-Based Medical Device Development
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What Does Quality Mean for Remote Work During COVID-19?

Ensuring Safety and Quality for Medical Device Development During Pandemic
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Case Study: Safe Health

How Sierra Labs helped Safe Health win enterprise customers with HITRUST and SOC2 Compliance.
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The Importance of SOC 2 Certification for Healthcare

How SOC 2 Certification provides security and value for Medical Device Companies.
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Untangling HIPAA, HITRUST, and SOC 2

Explore the differences and benefits of the following regulatory frameworks for SaMD.
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Guidance on HIPAA Compliance for Medical Devices

Defining HIPAA Compliance as it pertains to your Medical Device Company.
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What are CAPAs?

Learn the purpose of Corrective and Preventive Actions (CAPAs) for Medical Device Development.
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How to Create Successful SOPs for your Medical Device

Explore the key considerations for Standard Operating Procedures (SOPs) for Medical Device Companies
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What are Standard Operating Procedures (SOPs)?

Defining SOP’s as they pertain to your Medical Device.
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Crucial Do’s and Don’ts of SaMD Development

Explore the unique challenges and considerations of SaMD development.
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Using Agile in SaMD Development Under IEC 62304

Uncovering how Agile practices fulfill Software as a Medical Device Development
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What is FDA's 21 CFR Part 820?

Unpacking the FDA guidelines and regulations under 21 CFR Part 820.
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The Ultimate SaMD Development Plan

Easy ways to meet FDA Regulatory Requirements with your Software Development Plan
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4 Ways AAMI TIR45 Proves Beneficial for SaMD Development

Easy Guidance for SaMD Development and Agile Practices
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A Simple Guide to 510(k) Applications for Medical Devices

Easy Guidance for Abbreviated, Special, and Traditional 510(k) Clearance Applications
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6 Preliminary Questions Around FDA’s RTA Policy for 510(k)

Outlining the Preliminary Qualifications and Evaluation of FDA’s Updated RTA Policy for 510(k) Submissions
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5 Best Practices for Pharmaceutical Labeling

How strategic labeling can improve regulatory compliance and operational efficiency
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Quick Guide to a Successful Clinical Development Program

Unpacking the 4 stages of a Clinical Development Program.
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A Regulatory Approach Manual for Device Software Functions

Understanding the policies for your Medical Device Software Functions
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8 Guidelines for your Medical Device Regulatory Strategy

Learn how your company can form a Regulatory Strategy in 8 easy steps.
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5 Myths of Automation in Healthcare, Debunked!

Automation Myths standing in the way of progress in our healthcare system.
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6 Regulatory Pathways to Bring Your Medical Device to Market

Uncover which regulatory pathway is right for your medical device!
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5 Steps to Obtain a CE Marking on Your Medical Device

How to utilize ISO 13485 to acquire a CE Marking on your Medical Device.
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FDA’s Emergency Use Authorization (EUA) to Combat the Coronavirus

How Emergency Use Authorization is shaping the regulatory landscape of Healthcare during the COVID-19 pandemic.
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5 Crucial Ways Digital Health is Mitigating COVID-19

A deep dive into Digital Health's role in curbing this global coronavirus pandemic.
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How to Utilize CAPA in 10 Easy Steps

Step by step instructions on navigating your Corrective Action & Preventive Action (CAPA) for FDA.
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A Quick & Easy Guide to FDA Pre-Submissions

A simple guide to conquering your Pre-Submission Meeting with FDA, plus some free tools!
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Top 20 Medical Device Conferences to Attend in 2020

A simple breakdown of 20 conferences you don't want to miss this year.
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20 New FDA Biological Approvals in 2019

A comprehensive table of CBER's 20 new biological approvals and their corresponding approval dates, intended uses, and companies.
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48 New Drug FDA Approvals in 2019

A comprehensive table of the 48 new drug approvals and their corresponding active ingredients, diseases, estimated sales, and companies.
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The Secret to GxP Cloud Compliance in 4 Minutes or Less

Learn how to achieve GxP Cloud Compliance and simplify your Cloud Validation process with 1 simple trick.
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The Future of GxP Cloud Validation (It's Not What You Think!)

Here's how to conquer Cloud compliance in the regulated industry.
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3 Crucial Steps in Choosing the Right GxP Cloud Provider

What should be on your radar while tackling GxP Cloud Validation.
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How to Utilize GAMP to Achieve a GxP Cloud

Connecting the dots between Cloud technology and regulatory compliance.
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Demystifying AI in Healthcare

Boosting Your Knowledge of Artificial Intelligence while Analyzing its Crucial Role in Healthcare.
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Why Digital Health is Leading the Healthcare Space

Everything you need to know about digital health and its impact, opportunities, and challenges in the life science industry.
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Cannabis Compliance in 5 Minutes or Less

Everything you need to know about cannabis compliance and how it affects your business.
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What is ISO 13485:2016?

An easily digestible overview of ISO 13485 and how it applies to your medical device company.
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Medical Device Single Audit Program (MDSAP) Explained

A simple breakdown of MDSAP, how it can benefit your company, and detailed instructions on how to get started.
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ISO 13485 - Regulatory Requirements on Medical Devices

How embracing regulations can give you a leg up on your competition.
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FDA Pre-Cert 101: Beginner's Guide + Latest Updates

A simple breakdown of the Software Pre-Certification Program and how it affects your company.
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Medical Device Software & SaMDs: A Crash Course

A quick and easy rundown of ISO and IEC standards. 
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New Medical Device & Life Science Collaboration Platform

Sierra Policies Quick Start video out now!
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ISO 13485 vs. CFR Part 820

A comparative study on the key differences between FDA’s QSR and ISO’s QMS.
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ISO 14971 Risk Management in Under 5 Minutes

Defining medical device risk while taking a sneak peek into ISO 14971:2019.
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Shape the future of FDA Regulations for AI/ML.

The proposal for AI/ML based SaMD regulatory framework is out now and you can influence the FDA! 
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3 Steps to a GxP Cloud!

Do you want to transition to the cloud but have concerns about staying compliant?  Below is your 3 step success guide for a digital transformation to a GxP Compliant Cloud.
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A Simple Guide to SaMD

Breaking down the basics of Software as a Medical Device (SaMD): risk categorizations and examples.
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Embrace Agile in SaMD to stay competitive!

Learn how to implement Agile into your SaMD development and also stay compliant.
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