Predetermined Chance Control Plans for Machine Learning-Enabled Medical Devices
FDA Releases Guidance On Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices
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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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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)
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FDA and Cybersecurity for SaMD
The implications cybersecurity regulations and standards will have on your Medical Device development!
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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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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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4 Ways AAMI TIR45 Proves Beneficial for SaMD Development
Easy Guidance for SaMD Development and Agile Practices
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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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Know the basics about Meeting with the FDA for Medical Device Pre-Submissions.
Ready to bring your medical device to market? Find out how to navigate the pre-submission process with this essential guide.
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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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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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Advantages of a Quality Management System with Jira Integration
Risk management guide for Medical Device Companies on Atlassian’s Jira!
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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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8 Regulatory Strategy Guidelines for Your Medical Device
Learn how your company can form a Regulatory Strategy in 8 easy steps.
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What does FDA’s Draft Predetermined Change Control Plan PCCP for AIML-DSF recommend?
Marketing Submission Recommendations for a Predetermined Change Control Plan (PCCP) for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions
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Top 3 Requirements for Software as Medical Device (SaMD)
A deeper dive into crucial policies for Software for Medical Device (SaMD) Organizations
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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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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
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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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What Actually Happens in a Pre-Submission Meeting with FDA? Part II
How to get the most out of Pre-Submission meetings with the FDA.
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What Actually Happens in a Pre-Submission Meeting with FDA? Part I
Understanding the power of utilizing a pre-submission for your medical device.
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FDA Releases Guidance On Cybersecurity for Medical Devices
Why Cybersecurity is crucial in the Medical Device & SaMD Industry
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Why Sierra QMS is the Right System for Your Startup
How QMS is a crucial part of regulatory compliance for Medical Device Startups!
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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!
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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.
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Guide to HIPAA Compliance: Achieving & Maintaining Data Security
Step by step guide for obtaining HIPAA Compliance for your Healthcare or Life Science organization.
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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.
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Architecting Atlassian for Healthcare and FDA Compliance: Part 1
Bridging the gap between agile development for innovation and audit readiness for compliance!
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Architecting Atlassian for Healthcare and FDA Compliance: Part 2
Using Atlassian’s Jira framework to transform and boost DevOps!
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Case Study: Digiteyez Technologies
Digiteyez Technologies uses Sierra QMS to streamline compliance processes and tackle FDA regulations for their medical device, Clear.
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6 Steps for Implementing a QMS Software
Learn the right steps to adopting an eQMS for your Medical Device or Life Science organization.
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Sierra Labs Webinar: Digital Transformation in Healthcare
2021 Trends: Digital Transformation in Healthcare Webinar Recap + Helpful Resources
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Case Study: Transparency Life Sciences
How Sierra Labs and TLS Partnered to Streamline Their Quality Process
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Pro Tips Surrounding Design Controls for Medical Devices
Breaking Down Design Control Requirements for Medical Device Development Teams
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The Secret to a Successful Hardware Development Process
What is the right approach to developing hardware-based medical devices?
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The Ultimate Quality Management System for Life Sciences
Must-Have Features & Functionality for Your Quality Management System (QMS)
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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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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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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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Using Agile in SaMD Development Under IEC 62304
Uncovering how Agile practices fulfill Software as a Medical Device (SaMD) 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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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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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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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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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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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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