MedTech & Connected Devices

MDR compliance and product security,

not bolted on after the fact.

You're building a connected medical device. MDR compliance and product security aren't separate problems — they're both regulatory requirements and patient safety obligations. We help you design both in from day one and get it right before you go to market.

Services for MedTech Companies

Assessment Readiness Programme

Before you can certify, you need to be ready to be assessed. This programme prepares MedTech companies for IEC 81001-5-1 and ISO 27001 assessments. Identifying gaps, building your evidence base and making sure you're audit-ready before the auditors arrive.

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Board Cyber Governance Programme

Security governance isn't just for large organisations. This programme helps MedTech leadership teams build the frameworks, policies and reporting structures needed to demonstrate security governance to regulators, buyers and investors.

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Cyber Retainer

Ongoing cybersecurity advisory as your product evolves. Monthly regulatory and threat intelligence, compliance monitoring, quarterly product security review and incident readiness planning keeping you compliant at every stage of your growth.

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From €2,500/month · Limited places available.

Not sure which service is right for you?

Talk to our team and we'll point you in the right direction.