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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    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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