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Integrating FDA QMSR Requirements into Your Internal Audit
News Regulatory Compliance SaMD FDA
Integrating FDA QMSR Requirements into Your Internal Audit
Oct 20, 2025 2 min read
EU AI Act FAQ for Medical Device Manufacturers
International Regulatory Affairs Regulatory Compliance SaMD FDA
EU AI Act FAQ for Medical Device Manufacturers
Oct 15, 2025 2 min read
US Government Shutdown: FDA & Medical Device Impact
News Regulatory Compliance SaMD FDA
US Government Shutdown: FDA & Medical Device Impact
Oct 09, 2025 2 min read
Apple Watch Hypertension Notification: Regulatory Case Study
International Regulatory Affairs Regulatory Compliance SaMD FDA
Apple Watch Hypertension Notification: Regulatory Case Study
Sep 25, 2025 3 min read
FDA Computer Software Assurance 2025 Guidance
News Regulatory Compliance SaMD FDA
FDA Computer Software Assurance 2025 Guidance
Sep 25, 2025 4 min read
Rook Quality Systems Appoints Tyler to Lead Regulatory Strategy
News Audit Support General Regulatory Compliance FDA
Rook Quality Systems Appoints Tyler to Lead Regulatory Strategy
Sep 23, 2025 3 min read
FDA’s 2025 Cybersecurity Guidance for Medical Devices
Cybersecurity Regulatory Compliance SaMD FDA
FDA’s 2025 Cybersecurity Guidance for Medical Devices
Sep 23, 2025 2 min read
Health Canada Launches eSTAR Pilot for IVD Submissions
International Regulatory Affairs Regulatory Compliance
Health Canada Launches eSTAR Pilot for IVD Submissions
Sep 18, 2025 2 min read
Preparing for the transition from FDA QSR to QMSR
Regulatory Compliance FDA
Preparing for the transition from FDA QSR to QMSR
Sep 18, 2025 3 min read
Medical Device User Fees
Medical Device User Fees
Aug 06, 2025 3 min read
FDA Announces Full Recognition of IEC 612326-2-6
FDA Announces Full Recognition of IEC 612326-2-6
Aug 04, 2025 2 min read
ISO 10993‑1:2025 Approved & Pending Publication
ISO 10993‑1:2025 Approved & Pending Publication
Aug 04, 2025 3 min read
Regulatory Accelerator for Digital Health Innovators
Regulatory Accelerator for Digital Health Innovators
Jul 28, 2025 1 min read
FDA's Retirement of QSIT
FDA's Retirement of QSIT
May 22, 2025 1 min read
Ensuring the Safety & Effectiveness of AI Systems in Healthcare
Ensuring the Safety & Effectiveness of AI Systems in Healthcare
May 15, 2025 2 min read
Poor Quality
Poor Quality
May 13, 2025 4 min read
Challenges in Regulating AI-Enabled Medical Devices
Regulatory Compliance SaMD FDA
Challenges in Regulating AI-Enabled Medical Devices
Apr 16, 2025 3 min read
Have you scheduled your 2024 internal audit?
Audit Support
Have you scheduled your 2024 internal audit?
Dec 12, 2024 3 min read
Understanding How to Properly Evaluate Suppliers per FDA Requirements 21 CFR 820.50
Audit Support
Understanding How to Properly Evaluate Suppliers per FDA Requirements 21 CFR 820.50
Oct 25, 2024 3 min read
Small Business Determination Requests Now Accepted Through CDRH Portal
Small Business Determination Requests Now Accepted Through CDRH Portal
Oct 23, 2024 3 min read
FDA Draft Guidance on Chemical Analysis for Biocompatibility Assessment of Medical Devices
FDA Draft Guidance on Chemical Analysis for Biocompatibility Assessment of Medical Devices
Sep 26, 2024 3 min read
Advancing Innovation in Sterilization Processes: FDA’s Recognition of New Standards
Advancing Innovation in Sterilization Processes: FDA’s Recognition of New Standards
Sep 18, 2024 2 min read
Elevate Your Compliance with Rook Quality Systems’ “Quality as a Service” Offering
General
Elevate Your Compliance with Rook Quality Systems’ “Quality as a Service” Offering
Aug 28, 2024 2 min read
Expanding Horizons: Rook Quality Systems Now Offering Product Registration and License Holding Services in APAC
News
Expanding Horizons: Rook Quality Systems Now Offering Product Registration and License Holding Services in APAC
Aug 09, 2024 2 min read
Enhancing Transparency in Machine Learning – Enabled Medical Devices: Key Principles and Best Practices
Enhancing Transparency in Machine Learning – Enabled Medical Devices: Key Principles and Best Practices
Aug 01, 2024 4 min read
Empowering the SDLC with Tools to Bridge R&D and QA Teams
Empowering the SDLC with Tools to Bridge R&D and QA Teams
Jul 21, 2024 2 min read
The FDA’s Artificial Intelligence Program’s Role in Addressing Regulatory Challenges in AI-Driven Medical Devices
The FDA’s Artificial Intelligence Program’s Role in Addressing Regulatory Challenges in AI-Driven Medical Devices
Jul 19, 2024 2 min read
Key Strategies for Successfully Executing the Design Transfer Process
Key Strategies for Successfully Executing the Design Transfer Process
Jul 12, 2024 4 min read
Essential Tips for Preparing for Your ISO 13485:2016 Stage 1 Audit
Essential Tips for Preparing for Your ISO 13485:2016 Stage 1 Audit
Jul 11, 2024 3 min read
Mastering Cybersecurity in Medical Devices: Key Strategies and Tools
Jul 10, 2024 2 min read
Understanding the FDA’s Small Entity Compliance Guide for the LDT Final Rule
Understanding the FDA’s Small Entity Compliance Guide for the LDT Final Rule
Jun 26, 2024 2 min read
What is A Pre-Submission (Pre-Sub)?
What is A Pre-Submission (Pre-Sub)?
Jun 10, 2024 3 min read
Keeping Up with the Machine: Predetermined Change Control Plans for Medical Devices
Keeping Up with the Machine: Predetermined Change Control Plans for Medical Devices
Jun 07, 2024 4 min read
Navigating the Intricacies of Medical Device Software Regulations
Navigating the Intricacies of Medical Device Software Regulations
Jun 04, 2024 1 min read
FDA Labeling Requirements for Point of Care vs. Home Use Devices
FDA Labeling Requirements for Point of Care vs. Home Use Devices
May 10, 2024 2 min read
Navigating the FDA’s Final Rule on Lab-Developed Tests – LDTs
Navigating the FDA’s Final Rule on Lab-Developed Tests – LDTs
May 03, 2024 2 min read
Navigating Healthcare Cybersecurity: Section 524B of the FD&C Act
Navigating Healthcare Cybersecurity: Section 524B of the FD&C Act
Apr 11, 2024 2 min read
RookQS and Grasp Health Forge Dynamic Partnership
News
RookQS and Grasp Health Forge Dynamic Partnership
Apr 11, 2024 1 min read
Streamlining Success: Rook Quality Systems’ Comprehensive Clinical Evaluation Services for Medical Device Clients
Streamlining Success: Rook Quality Systems’ Comprehensive Clinical Evaluation Services for Medical Device Clients
Apr 11, 2024 2 min read
A Guide to Etiquette and Preparation for Your First FDA Audit
A Guide to Etiquette and Preparation for Your First FDA Audit
Mar 08, 2024 1 min read
Guidelines for Verifying Laboratory Testing Data Before FDA Submission
Guidelines for Verifying Laboratory Testing Data Before FDA Submission
Mar 06, 2024 1 min read
QMSR Final Rule Webinar
QMSR Final Rule Webinar
Feb 16, 2024
FDA Proposes New Regulations For Laboratory Developed Tests
FDA Proposes New Regulations For Laboratory Developed Tests
Feb 13, 2024 1 min read
6 Bold Predictions for Medical Device Quality in 2024
Cybersecurity MDR
6 Bold Predictions for Medical Device Quality in 2024
Jan 26, 2024 2 min read
Rook QS Joins Forces with Trust Cybersecurity for Unparalleled Defense
News
Rook QS Joins Forces with Trust Cybersecurity for Unparalleled Defense
Jan 13, 2024 1 min read
Understanding the FDA Changes to LDT Regulations
Understanding the FDA Changes to LDT Regulations
Dec 05, 2023 3 min read
FDA’s Move to Lower 510(k) Submissions to Aid Virtual Health Care
FDA’s Move to Lower 510(k) Submissions to Aid Virtual Health Care
Nov 06, 2023 3 min read
Road to Market for Wearable Medical Devices
Road to Market for Wearable Medical Devices
Nov 03, 2023 5 min read
The Future Regulation of Laboratory-Developed Tests (LDTs)
The Future Regulation of Laboratory-Developed Tests (LDTs)
Oct 03, 2023 2 min read
Steps the FDA Continues to Take to Strengthen the Premarket Notification [510(k)] Program
Steps the FDA Continues to Take to Strengthen the Premarket Notification [510(k)] Program
Sep 20, 2023 3 min read
What To Do (And What Not To Do) When You Receive a FDA Audit Notice
Audit Support
What To Do (And What Not To Do) When You Receive a FDA Audit Notice
Aug 16, 2023 3 min read
Risk Management in the Medical Device Industry – Part 2
Risk Management in the Medical Device Industry – Part 2
Aug 16, 2023 2 min read
Risk Management in the Medical Device Industry
Risk Management in the Medical Device Industry
Aug 01, 2023 3 min read
Where does AI meet the Medical Device Industry?
Where does AI meet the Medical Device Industry?
Jul 06, 2023 3 min read
FDA Releases Updates on Software Guidance
FDA Releases Updates on Software Guidance
Jun 27, 2023 3 min read
The Costs of Entering the EU Market
The Costs of Entering the EU Market
Jun 01, 2023
From Pandemic to Endemic: What Should Medical Device Manufacturers Do for COVID-19 Transition?
International Regulatory Affairs
From Pandemic to Endemic: What Should Medical Device Manufacturers Do for COVID-19 Transition?
May 26, 2023 4 min read
The Partnership Continues: Greenlight Guru to offer RookQS SaMD Templates
The Partnership Continues: Greenlight Guru to offer RookQS SaMD Templates
May 12, 2023 2 min read
QA/RA Implications of the New ‘Predetermined Change Control Plans’ Guidance
QA/RA Implications of the New ‘Predetermined Change Control Plans’ Guidance
Apr 14, 2023 6 min read
Shining A Light on MDR Notified Body Standard Fees
International Regulatory Affairs
Shining A Light on MDR Notified Body Standard Fees
Mar 23, 2023 2 min read
When to Start Preparing for the IVDR
International Regulatory Affairs
When to Start Preparing for the IVDR
Feb 03, 2023 4 min read
Medical Device Cybersecurity
Medical Device Cybersecurity
Feb 03, 2023 8 min read
How to Prepare Human Factors Documentation for the FDA Premarket Submission
How to Prepare Human Factors Documentation for the FDA Premarket Submission
Feb 03, 2023 5 min read
Internal Audits & Annual Physicals: Is Ignorance Really Bliss?
Audit Support
Internal Audits & Annual Physicals: Is Ignorance Really Bliss?
Feb 03, 2023 2 min read
5 BOLD Predictions for Medical Device Quality in 2023
MDR
5 BOLD Predictions for Medical Device Quality in 2023
Jan 10, 2023 2 min read
APAC (Asia-Pacific) Medical Device Regulatory Landscape
International Regulatory Affairs
APAC (Asia-Pacific) Medical Device Regulatory Landscape
Dec 09, 2022 3 min read
How to Simplify Medical Device Reporting Set-Up
How to Simplify Medical Device Reporting Set-Up
Dec 06, 2022 2 min read
Medical Device Development Tools (MDDT)
International Regulatory Affairs
Medical Device Development Tools (MDDT)
Dec 02, 2022 4 min read
Understanding the FDA’s Final CDS Guidance
International Regulatory Affairs
Understanding the FDA’s Final CDS Guidance
Nov 23, 2022 4 min read
Leveraging AI for Enhanced Healthcare Delivery
Leveraging AI for Enhanced Healthcare Delivery
Nov 23, 2022 2 min read
UKCA Mark Delay – How to Capitalize on the Extension
MDR International Regulatory Affairs
UKCA Mark Delay – How to Capitalize on the Extension
Nov 07, 2022 3 min read
MedTech Software Verification and Validation
MedTech Software Verification and Validation
Sep 30, 2022 3 min read
Challenges of SaMD (Software as a Medical Device) Product Development
Challenges of SaMD (Software as a Medical Device) Product Development
Sep 12, 2022 3 min read
Software as a Medical Device (SaMD) Audit Challenges
Audit Support
Software as a Medical Device (SaMD) Audit Challenges
Sep 01, 2022 5 min read
Best Practices For a SaMD MDR Application
MDR
Best Practices For a SaMD MDR Application
Aug 18, 2022 2 min read
Preparing For Your First FDA or ISO Audit
Aug 09, 2022
FDA Q-Submission Program: What You Need To Know
International Regulatory Affairs
FDA Q-Submission Program: What You Need To Know
Aug 05, 2022 3 min read
FDA eSTAR Program: Three Main Benefits
General
FDA eSTAR Program: Three Main Benefits
Jul 06, 2022 2 min read
How To Prepare For Your First FDA Audit
Audit Support International Regulatory Affairs
How To Prepare For Your First FDA Audit
Jun 27, 2022 2 min read
MDR Transition and Technical Files: What You Need to Know
Jun 10, 2022
How To Prepare For Your First ISO Audit
Audit Support International Regulatory Affairs
How To Prepare For Your First ISO Audit
May 20, 2022 4 min read
What Should (and Shouldn’t) Go In a Technical File for MDR?
MDR International Regulatory Affairs
What Should (and Shouldn’t) Go In a Technical File for MDR?
Apr 28, 2022 2 min read
Podcasts
FDA’s ISO 13485 Transition Plan … What Does it Mean for Your Medtech’s Quality Plan?
Apr 27, 2022
COVID-19 EUA and Enforcement Policy Transition Plans
COVID-19 EUA and Enforcement Policy Transition Plans
Apr 12, 2022 4 min read
Rook Quality Systems: Celebrating a Decade of Gratitude and Growth
News General
Rook Quality Systems: Celebrating a Decade of Gratitude and Growth
Mar 20, 2022 3 min read
FDA ISO Harmonization: What Does It Mean, and What Should We Do Next?
MDR
FDA ISO Harmonization: What Does It Mean, and What Should We Do Next?
Feb 23, 2022 2 min read
MDR Transition: Why the Change, and What are the Changes?
MDR
MDR Transition: Why the Change, and What are the Changes?
Feb 16, 2022 1 min read
Peace of Mind At Your Fingertips: Digital Health Funding Explodes
Peace of Mind At Your Fingertips: Digital Health Funding Explodes
Jan 17, 2022 3 min read
5 BOLD Predictions for Medical Device Quality in 2022
MDR
5 BOLD Predictions for Medical Device Quality in 2022
Dec 21, 2021 2 min read
‘Tis the Season … for an Internal Audit
Audit Support
‘Tis the Season … for an Internal Audit
Dec 13, 2021 2 min read
RQS Webinar: First FDA Software Updates in 16 Years
SaMD Support Webinars Webinars
RQS Webinar: First FDA Software Updates in 16 Years
Nov 23, 2021
FDA Updates Software Guidance (Part II of II)
FDA Updates Software Guidance (Part II of II)
Nov 09, 2021 2 min read
FDA Updates Software Guidance (Part I of II)
FDA Updates Software Guidance (Part I of II)
Nov 04, 2021 2 min read
Align Agile Practices with QMS Requirements
Align Agile Practices with QMS Requirements
Aug 06, 2021 3 min read
New FDA Guidance Regarding Bench Testing
New FDA Guidance Regarding Bench Testing
May 17, 2021 1 min read
Five action items to address Artificial Intelligence/Machine Learning- based SaMD
Five action items to address Artificial Intelligence/Machine Learning- based SaMD
Apr 20, 2021 2 min read
Software as Medical Device (SaMD) Challenges and Opportunities for 2021 and Beyond Webinar
Jan 11, 2021 2 min read
FDA Digital Health Center of Excellence Listening Sessions
Regulatory Compliance DHCoE SaMD FDA IMDRF
FDA Digital Health Center of Excellence Listening Sessions
Jan 11, 2021 3 min read
Software Development Process for Healthcare Applications
Software Development Process for Healthcare Applications
Nov 09, 2020 2 min read
Audit Support Webinars
Understanding the Medical Device Single Audit Program and How to Prepare for it
Nov 05, 2020
Enforcement Policy from the FDA to combat COVID-19
Enforcement Policy from the FDA to combat COVID-19
Nov 05, 2020 2 min read
Documentation impacted by EU MDR
MDR
Documentation impacted by EU MDR
Nov 05, 2020 1 min read
MDR
Preparing your QMS for EU MDR
Nov 05, 2020
Enforcement Policy — Digital Health Devices For Treating Psychiatric Disorders During COVID-19
Enforcement Policy — Digital Health Devices For Treating Psychiatric Disorders During COVID-19
Nov 05, 2020 3 min read
Podcasts
Tips, Tricks, and Best Practices for Complying with ISO13485:2016
Nov 05, 2020 1 min read
Key Considerations for SaMD Companies Developing and Commercializing Software as Medical Devices
Nov 05, 2020 1 min read
Podcasts
What are the regulatory expectations for Software as a Medical Device (SaMD)?
Nov 05, 2020
Rook Quality System Announces Taiwan Branch Office
News
Rook Quality System Announces Taiwan Branch Office
Nov 05, 2020 1 min read
MDR
How to Conquer Supplier Management for Medical Device Companies
Nov 05, 2020
Work From Home Tips
Quality Training
Work From Home Tips
Nov 05, 2020 1 min read
Regulatory requirements for medical device software
Regulatory requirements for medical device software
Nov 04, 2020 3 min read
Podcasts
Implementing Changes to SaMD under new EU MDR
Oct 11, 2020
What is Software as a Medical Device (SaMD)?
What is Software as a Medical Device (SaMD)?
Sep 09, 2020 1 min read
Classification and Qualification of SaMD under MDR
Classification and Qualification of SaMD under MDR
Jun 01, 2020 3 min read
How do startups leverage FDA’s Pre-Cert Working Model – Part 2
How do startups leverage FDA’s Pre-Cert Working Model – Part 2
Mar 10, 2020 4 min read
How to Leverage the FDA Pre-Cert Program: Part 1
Regulatory Compliance SDLC ExcellenceAppraisal SaMD FDA
How to Leverage the FDA Pre-Cert Program: Part 1
Mar 09, 2020 3 min read
Medical Device Regulation – Getting Started Soon
MDR
Medical Device Regulation – Getting Started Soon
Feb 15, 2020 3 min read
The Essential Guide to Preparing Your QMS For EU MDR
The Essential Guide to Preparing Your QMS For EU MDR
Sep 20, 2019 1 min read
Importance of Software Testing on Software as Medical Device (SaMD)
Importance of Software Testing on Software as Medical Device (SaMD)
May 09, 2019 2 min read
8 Questions about the European MDR Answered
MDR
8 Questions about the European MDR Answered
Apr 30, 2019
FDA’s take on Digital Health Regulatory Paradigm Shift
FDA’s take on Digital Health Regulatory Paradigm Shift
Apr 09, 2019 3 min read
Understanding The New Requirements for QMS Software Validation in ISO 13485:2016
Regulatory Compliance
Understanding The New Requirements for QMS Software Validation in ISO 13485:2016
Jun 09, 2016 4 min read

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