Medical Devices
Secure your systems and stay ready for EUDAMED and MDR audits.
Control access, protect Design History Files, and keep records ready for a notified body before they ask.
Design History File and EUDAMED Registration Risks
Medical Devices
Access is not kept tight as teams change
A departing employee's login staying active is exactly the gap a notified body looks for first.
Design History Files are not consistently traceable
Changes to DHF and CAPA records need a clear log kept current in real time, since a reconstructed trail is the first thing a notified body questions.
EUDAMED registration is not yet in place
Four modules become mandatory on 28 May 2026, and registration takes longer to complete than teams generally plan for, leaving a scramble against a hard deadline for anyone who starts late.
MDR IT Requirements for Medical Device Companies in Ireland
The expectation has shifted from having records to proving them on demand.
That means you can show:
• ISO 27001 aligned cybersecurity governance
• endpoint monitoring and proactive patching
• governed access with a clear audit trail
• consistent, auditable DHF and CAPA records
• EUDAMED registration in place ahead of the deadline
Notified Body Audit and Cybersecurity Risks
Risk builds where regulated design data sits across systems with access that hasn’t kept pace with staff and site changes.
Add a notified body review and a gap in the change log, and a small oversight becomes extra audit scrutiny, unless it’s managed deliberately.
Managed IT for Medical Device Companies in Ireland
Hybrid reduces risk and strengthens traceability through consistent delivery. Centralised Services logs every change to your DHF and CAPA records, preserving traceability through a notified body review, and removes access as soon as someone leaves. Your TAM then reviews that traceability against MDR obligations and flags any remaining gaps. An engineer who already understands medical device environments picks up fast when something breaks.
Want a clear view of your biggest exposure points?
Cyber Security Services
Threat Detection and Prevention
- Proactive Threat Protection: We deploy layered threat protection across your entire environment using licensed firewalls (SonicWall, Cisco, Meraki, Unifi, Ubiquiti, TP Link), antivirus (BitDefender, ESET, Microsoft Defender), and email scanning (Vade, Defender) to detect and neutralise threats in real time.
- Multi-Factor Authentication: We secure every login with MFA, adding an extra layer of verification that stops unauthorised access before it becomes a breach.
Watch Our Webinar to learn more about a live ransomware attack and about the top solutions out there to protect your data.
Security Audits and Compliance
- Regular Audits: Ensuring your business meets all necessary regulatory requirements, keeping you compliant and secure.
- ISO 27001: Conduct a GAP analysis to identify security gaps, prioritizing issues using a traffic light system for efficient resolution, ensuring ongoing adherence to ISO 27001 standard and other regulations.
Gain insights from our ISO 27001 Case Study and its impact on business.
Business Continuity and Disaster Recovery (BCDR)
We build recovery strategies designed to restore your business operations fast after any disruption, keeping your data protected and your team back online as quickly as possible.
- Minimise Downtime: Our Recovery Point Objective (RPO) ensures backups run three times a day, minimising data loss and keeping your business as close to normal as possible.
- Fast System recovery: Our Recovery Time Objective (RTO) focuses on getting your systems back online quickly, powered by Datto RMM to reduce the time your business is offline.
- Backup Integration: We ensure data integrity and continuous protection through proactive backups, fully integrated with Datto RMM.
What’s your Plan B? Every Irish business needs one.
Get in Touch with our team today and we will build a BCDR plan around your business.
Software Security Patching
- Proactive Patch Management: Testing and deploying security updates after thorough evaluation.
- Comprehensive Service: Managing the patching process, including server-related and Microsoft Windows server updates.
Stay Up to Date and ensure your software is secure with our patching service.
Remote Monitoring and Management (RMM)
- Endpoint Monitoring: Continuous monitoring of every device, catching issues before they reach your business.
- Integrated SOC and EDR Services: SOC and EDR combined to detect and respond to threats across every endpoint.
- Automated Maintenance: Software updates and security patching automated, keeping your systems secure and current.
Incident Response and Recovery
Immediate Action: Preparedness to respond swiftly to any security incidents to protect business continuity.
Respond to Threats and Contact Us for rapid incident response.
Employee Training and Awareness
- Security Awareness Training: We equip your team with the knowledge to recognise phishing attempts, social engineering, and cyber threats before they cause damage.
- Phishing Simulation Tests: We run realistic phishing simulations to test and strengthen your team’s ability to spot and respond to real-world attacks.
Why Choose Us for Cybersecurity and Monitoring
“The question is never if your business will be targeted. The question is whether you will be ready.” – Paul Browne, MD
When you choose us for cybersecurity and monitoring, you get more than protection. You get a dedicated team of security engineers who know your environment, respond fast, and treat your security as their own responsibility.
Frequently Asked Questions
What is EUDAMED and when do I need to register?
EUDAMED is the EU’s central database for medical device regulatory data. Four modules become mandatory on 28 May 2026 for every manufacturer placing devices on the Irish market.
Where do medical device cybersecurity risks typically come from?
Risks build through access that hasn’t kept pace with staff changes, Design History Files with gaps in the change log, and EUDAMED registration left until the deadline.
Do medical device companies need ISO 27001 certification?
It sits outside MDR’s direct mandate, but manufacturers increasingly pursue it to strengthen the cybersecurity governance a notified body expects to see.