Skip to content
8foldgovernance master
  • Services
    • AI Governance
    • Medical Devices
      • Regulatory Roadmap
      • ISO 13485 Design & Build your QMS
      • Quality Management as a Service
      • Technical File Creation & Registration
      • UK Responsible Person
      • Post Market Surveillance
    • International Standards
      • ISO 13485 Certification
      • ISO 42001 Certification
      • ISO 9001 Certification
      • ISO 27001 Certification
    • DTAC
      • DTAC Management
    • Information Governance
      • Data Security & Protection (DSPT)
      • DSPT Audit
      • HIPAA Compliance
    • Clinical Safety and Risk Management
      • DCB0129
      • DCB0160
      • Clinical Safety Officers (CSO)
    • CQC Services
      • CQC Compliance Assessment
      • CQC Registration Support
      • CQC-as-a-Service
      • CQC Regulatory Review & Strategy
    • Cyber Security
    • Governance, Risk & Compliance Advisory
    • 8foldTraining
  • About
    • Meet the Team
    • Partnerships
    • Join Us
  • Blog
  • Case Studies
  • Contact
  • Services
    • AI Governance
    • Medical Devices
      • Regulatory Roadmap
      • ISO 13485 Design & Build your QMS
      • Quality Management as a Service
      • Technical File Creation & Registration
      • UK Responsible Person
      • Post Market Surveillance
    • International Standards
      • ISO 13485 Certification
      • ISO 42001 Certification
      • ISO 9001 Certification
      • ISO 27001 Certification
    • DTAC
      • DTAC Management
    • Information Governance
      • Data Security & Protection (DSPT)
      • DSPT Audit
      • HIPAA Compliance
    • Clinical Safety and Risk Management
      • DCB0129
      • DCB0160
      • Clinical Safety Officers (CSO)
    • CQC Services
      • CQC Compliance Assessment
      • CQC Registration Support
      • CQC-as-a-Service
      • CQC Regulatory Review & Strategy
    • Cyber Security
    • Governance, Risk & Compliance Advisory
    • 8foldTraining
  • About
    • Meet the Team
    • Partnerships
    • Join Us
  • Blog
  • Case Studies
  • Contact
  • +44 (0)1273 569172
Book a Call

Dan York

Read More
Dan has over 6 years of experience working within regulated environments and quality management systems. His career has seen him handling implementation and continual improvement of processes and procedures within In Vitro Diagnostics (IVD) manufacturing, veterinary laboratory and Software as a Medical Device (SaMD) products. He strongly believes in the effectiveness of quality management systems as tools to lead to better healthcare and business outcomes and promotes practical and straightforward compliance solutions. Dan has worked with organisations on system implementation, management and audit preparation for medical devices subject to a wide range of ever-evolving global regulatory requirements. Outside of work, Dan brings his passion for systems and communication to a love of boardgames. Not only playing them, you’ll also find him writing about tabletop games and actively involved in his local game design community too.
Headshot of a man with long hair, a beard and glasses, wearing a patterned shirt

Blog Categories :

  • All posts
  • Artificial Intelligence
  • Case Studies
  • Clinical Safety
  • CQC
  • Cyber Security
  • DSPT
  • DTAC
  • Expert Insights
  • Industry Insights
  • Information Governance
  • International Standards
  • Medical Devices
  • Social Purpose
  • All posts
  • Artificial Intelligence
  • Case Studies
  • Clinical Safety
  • CQC
  • Cyber Security
  • DSPT
  • DTAC
  • Expert Insights
  • Industry Insights
  • Information Governance
  • International Standards
  • Medical Devices
  • Social Purpose
Loading...
IEC 62304 vs EU MDR classification
Headshot of a man with long hair, a beard and glasses, wearing a patterned shirt
Dan York

Implementing IEC 62304: 5 Common Mistakes

Posted In: Medical Devices
Published: July 3, 2026
IEC 62304 is the international standard which describes best practice in the development and verification of medical device software - that is,...
Read article
How to Register Your Medical Device with the MHRA
Headshot of a man with long hair, a beard and glasses, wearing a patterned shirt
Dan York

How to register your Medical Device with the MHRA

Posted In: Medical Devices
Published: December 16, 2025
Registering your, Medical device There are many stages involved with taking a medical device product from brilliant idea to a fully realised...
Read article
How ISO 42001 Compliments Other Regulatory Frameworks
Headshot of a man with long hair, a beard and glasses, wearing a patterned shirt
Dan York

How ISO 42001 Compliments Other Regulatory Frameworks

Posted In: International Standards
Published: November 26, 2025
Why should you implement ISO 42001? The pace of AI implementation into new products and settings is increasing rapidly. While machine learning...
Read article
Blog post: How to integrate ISO 42001 with other Management Systems
Headshot of a man with long hair, a beard and glasses, wearing a patterned shirt
Dan York

How to integrate ISO 42001 with other Management Systems

Posted In: International Standards
Published: October 8, 2025
ISO 42001 is the new Management System standard for governing AI systems, specifically the risks they present to your business, and providing...
Read article
Headshot of a man with long hair, a beard and glasses, wearing a patterned shirt
Dan York

Expert Insights: How AI will impact your ISO 13485 Quality Management System

Posted In: Medical Devices
Published: July 18, 2025
With the increasing power and accessibility of AI systems, more and more medical devices and IVDs are integrating artificial intelligence. This could...
Read article
Implementing ISO 27001:
Headshot of a man with long hair, a beard and glasses, wearing a patterned shirt
Dan York

Implementing ISO 27001: Things to Consider

Posted In: International Standards
Published: May 26, 2025
ISO 27001 is an international standard, a document created by the International Organisation for Standardisation, which sets out best practices for creating...
Read article
Preparing for SaMD Regulation
Headshot of a man with long hair, a beard and glasses, wearing a patterned shirt
Dan York

Expert Insights: SaMD Curious? Preparing to become a Regulated Medical Device

Posted In: Medical Devices
Published: March 10, 2025
Introduction to SaMD The use of specialist software in the healthcare industry is ever-increasing. Even if they are not currently a medical...
Read article
Expert Insights: Regulating Imaging Software
Headshot of a man with long hair, a beard and glasses, wearing a patterned shirt
Dan York

Expert Insights: Regulating Imaging Software

Posted In: Medical Devices
Published: February 28, 2025
Introduction Radiology Imaging Software (RIS) can be a powerful tool for clinicians all along the oncology pipeline. The technology has opened up...
Read article
UK MDR 2024 - Post Market Surveillance and Vigilance: What you need to know
Headshot of a man with long hair, a beard and glasses, wearing a patterned shirt
Dan York

FAQ: UK MDR 2024 – Post Market Surveillance and Vigilance: What you need to know

Posted In: Medical Devices
Published: February 6, 2025
Stay up to date with Post Market Surveillance practices! A major update to UK Medical Device Regulations 2002 was recently approved in...
Read article
FAQ:What is ISO 27001?
Headshot of a man with long hair, a beard and glasses, wearing a patterned shirt
Dan York

FAQ:What is ISO 27001?

Posted In: International Standards
Published: January 27, 2025
With healthcare innovation rapidly evolving and AI businesses leveraging vast amounts of confidential data, ISO 27001 stands as a foundation of information...
Read article
8foldgovernance master

+44 (0) 1273 569172

info@8foldgovernance.com

SERVICES

  • AI Governance
  • Medical Device Registration
  • ISO Compliance
  • Full DTAC Support
  • Information Governance
  • Clinical Safety
  • Data Security & Protection
  • CQC Services
  • Cyber Security
  • 8foldTraining

LINKS

  • Contact
  • About
  • Meet The Team
  • Blog
  • Join Us
  • Case Studies
  • Charity Work
  • Partnerships
  • FAQs
DSPT Data Security And protection Toolkit 8Fold
Information Governance Badge 8 Fold
NPSORE
ABHI Member

 © 2026 8fold | Privacy Policy | Cookie Policy | Terms & Conditions

X We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. By clicking “Accept”, you consent to the use of ALL the cookies. However you may visit Cookie Settings to provide a controlled consent.
Read More ACCEPT Cookie settings
Manage consent

Privacy Overview

This website uses cookies to improve your experience while you navigate through the website. Out of these cookies, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may have an effect on your browsing experience.
Necessary
Always Enabled
Necessary cookies are absolutely essential for the website to function properly. These cookies ensure basic functionalities and security features of the website, anonymously.
CookieDurationDescription
cookielawinfo-checkbox-analytics11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".
cookielawinfo-checkbox-functional11 monthsThe cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".
cookielawinfo-checkbox-necessary11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-others11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other.
cookielawinfo-checkbox-performance11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance".
viewed_cookie_policy11 monthsThe cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.
Functional
Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features.
Performance
Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors.
Analytics
Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc.
Advertisement
Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads.
Others
Other uncategorized cookies are those that are being analyzed and have not been classified into a category as yet.
Save & Accept