Rebecca Wilson
Founder, CEO & Director of Clinical Safety
ISO standards & QMS
ISO 13485, ISO 27001, ISO 9001 and ISO 42001, done properly
From gap analysis to certification readiness, we build quality and security management systems that fit how your team actually works.
Why ISO matters in digital health
NHS buyers, notified bodies and international partners increasingly expect recognised standards. ISO 13485 underpins medical device quality, ISO 27001 evidences information security, ISO 9001 shows consistent quality, and ISO 42001 sets out how you govern AI.
We connect these with your DCB0129, DTAC v2 and medical device work so you run one joined up system, not four separate ones.
What we deliver
- Gap analysis against each standard, with a clear plan
- ISO 13485 QMS build for medical device manufacturers
- ISO 27001 information security management system
- ISO 9001 quality management system
- ISO 42001 AI management system and EU AI Act alignment
- Internal audit, certification readiness and ongoing support
Frequently asked questions
Which ISO standards do digital health suppliers need?
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It depends on your product. ISO 13485 is the quality management standard for medical device manufacturers. ISO 27001 covers information security and is often requested by NHS buyers. ISO 9001 is a general quality management standard. ISO 42001 is the AI management system standard for organisations building or deploying AI.
Do I need ISO 13485 for a Class I medical device?
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UK MDR does not strictly require ISO 13485 certification for Class I devices, but you must operate a quality management system. Most manufacturers build their QMS to ISO 13485 so they are ready to move up a class or enter other markets.
Is ISO 27001 required for DTAC?
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DTAC does not mandate ISO 27001, but it asks for strong technical security evidence. ISO 27001, Cyber Essentials Plus and the Data Security and Protection Toolkit all help you answer it with confidence.
Can you run a gap analysis first?
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Yes. Most clients start with a gap analysis so they know exactly what is needed, in what order, before committing to certification.
Related services
Talk to an Expert
Book a free call with a DigiSafe expert. We'll scope the work, timelines and the right partnership, plain English, no jargon.
Direct clinical access
Meet the team, Clinical Safety Officers, DPOs & Medical Device Experts.
Multi-disciplinary lived experience across nursing, GP, paramedic, pharmacy, medical devices and data protection. Book a discovery call and we'll match you with the right expert.
Suzanne Ash
Medical Device and Compliance Lead
Stacey Dudley
Chief Operating Officer
Steve Robson
Senior CSO, Nurse
Dr Lizzie Marston
Senior CSO, GP
Mona Kapinga
Senior CSO, Pharmacist
Matthew Olsson
Senior CSO, Lead Trainer, Paramedic
Zara Mahmood
CSO, Occupational Therapist
Dr Stephen Eberwein
CSO, GP
Sharon Fisher
Executive Assistant
Every engagement starts with a free 20-min scoping call, a conflict-of-interest check, and a plain-English summary before you commit.