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Blog
FDA's Retirement of QSIT
May 22, 2025
1 min read
Ensuring the Safety & Effectiveness of AI Systems in Healthcare
May 15, 2025
2 min read
Poor Quality
May 13, 2025
4 min read
Regulatory Compliance
SaMD
FDA
Challenges in Regulating AI-Enabled Medical Devices
Apr 16, 2025
3 min read
Audit Support
Have you scheduled your 2024 internal audit?
Dec 12, 2024
3 min read
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
Oct 23, 2024
3 min read
FDA Draft Guidance on Chemical Analysis for Biocompatibility Assessment of Medical Devices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
Sep 18, 2024
2 min read
General
Elevate Your Compliance with Rook Quality Systems’ “Quality as a Service” Offering
Aug 28, 2024
2 min read
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
Aug 01, 2024
4 min read
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
Jul 19, 2024
2 min read
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
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
Jun 26, 2024
2 min read
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
Jun 07, 2024
4 min read
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
May 10, 2024
2 min read
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
Apr 11, 2024
2 min read
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
Apr 11, 2024
2 min read
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
Mar 06, 2024
1 min read
QMSR Final Rule Webinar
Feb 16, 2024
FDA Proposes New Regulations For Laboratory Developed Tests
Feb 13, 2024
1 min read
Cybersecurity
MDR
6 Bold Predictions for Medical Device Quality in 2024
Jan 26, 2024
2 min read
News
Rook QS Joins Forces with Trust Cybersecurity for Unparalleled Defense
Jan 13, 2024
1 min read
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
Nov 06, 2023
3 min read
Road to Market for Wearable Medical Devices
Nov 03, 2023
5 min read
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
Sep 20, 2023
3 min read
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
Aug 16, 2023
2 min read
Risk Management in the Medical Device Industry
Aug 01, 2023
3 min read
Where does AI meet the Medical Device Industry?
Jul 06, 2023
3 min read
FDA Releases Updates on Software Guidance
Jun 27, 2023
3 min read
The Costs of Entering the EU Market
Jun 01, 2023
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
May 12, 2023
2 min read
QA/RA Implications of the New ‘Predetermined Change Control Plans’ Guidance
Apr 14, 2023
6 min read
International Regulatory Affairs
Shining A Light on MDR Notified Body Standard Fees
Mar 23, 2023
2 min read
International Regulatory Affairs
When to Start Preparing for the IVDR
Feb 03, 2023
4 min read
Medical Device Cybersecurity
Feb 03, 2023
8 min read
How to Prepare Human Factors Documentation for the FDA Premarket Submission
Feb 03, 2023
5 min read
Audit Support
Internal Audits & Annual Physicals: Is Ignorance Really Bliss?
Feb 03, 2023
2 min read
MDR
5 BOLD Predictions for Medical Device Quality in 2023
Jan 10, 2023
2 min read
International Regulatory Affairs
APAC (Asia-Pacific) Medical Device Regulatory Landscape
Dec 09, 2022
3 min read
How to Simplify Medical Device Reporting Set-Up
Dec 06, 2022
2 min read
International Regulatory Affairs
Medical Device Development Tools (MDDT)
Dec 02, 2022
4 min read
International Regulatory Affairs
Understanding the FDA’s Final CDS Guidance
Nov 23, 2022
4 min read
Leveraging AI for Enhanced Healthcare Delivery
Nov 23, 2022
2 min read
MDR
International Regulatory Affairs
UKCA Mark Delay – How to Capitalize on the Extension
Nov 07, 2022
3 min read
MedTech Software Verification and Validation
Sep 30, 2022
3 min read
Challenges of SaMD (Software as a Medical Device) Product Development
Sep 12, 2022
3 min read
Audit Support
Software as a Medical Device (SaMD) Audit Challenges
Sep 01, 2022
5 min read
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
International Regulatory Affairs
FDA Q-Submission Program: What You Need To Know
Aug 05, 2022
3 min read
General
FDA eSTAR Program: Three Main Benefits
Jul 06, 2022
2 min read
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
Audit Support
International Regulatory Affairs
How To Prepare For Your First ISO Audit
May 20, 2022
4 min read
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
Apr 12, 2022
4 min read
News
General
Rook Quality Systems: Celebrating a Decade of Gratitude and Growth
Mar 20, 2022
3 min read
MDR
FDA ISO Harmonization: What Does It Mean, and What Should We Do Next?
Feb 23, 2022
2 min read
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
Jan 17, 2022
3 min read
MDR
5 BOLD Predictions for Medical Device Quality in 2022
Dec 21, 2021
2 min read
Audit Support
‘Tis the Season … for an Internal Audit
Dec 13, 2021
2 min read
SaMD Support Webinars
Webinars
RQS Webinar: First FDA Software Updates in 16 Years
Nov 23, 2021
At Long Last: FDA Updates Software Guidance (Part II of II)
Nov 09, 2021
2 min read
At Long Last: FDA Updates Software Guidance (Part I of II)
Nov 04, 2021
2 min read
Align Agile Practices with QMS Requirements
Aug 06, 2021
3 min read
New FDA Guidance Regarding Bench Testing
May 17, 2021
1 min read
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
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
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
Nov 05, 2020
2 min read
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
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
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
Quality Training
Medical Device QA – Work From Home Tips
Nov 05, 2020
1 min read
The Essentials: 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)?
Sep 09, 2020
1 min read
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
Mar 10, 2020
4 min read
Regulatory Compliance
SDLC
ExcellenceAppraisal
SaMD
FDA
How to Leverage the FDA Pre-Cert Program: Part 1
Mar 09, 2020
3 min read
MDR
Medical Device Regulation – Getting Started Soon
Feb 15, 2020
3 min read
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)
May 09, 2019
2 min read
MDR
8 Questions about the European MDR Answered
Apr 30, 2019
FDA’s take on Digital Health Regulatory Paradigm Shift
Apr 09, 2019
3 min read
Regulatory Compliance
Understanding The New Requirements for QMS Software Validation in ISO 13485:2016
Jun 09, 2016
4 min read
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