Rebecca Wilson
Founder, CEO & Director of Clinical Safety
What is ISO 13485?
ISO 13485 is the international standard for quality management systems for medical devices. It sets out how you design, develop, produce and support a device safely and consistently.
UK MDR requires manufacturers to operate a quality management system, and most build it to ISO 13485 so they can move up a device class or enter other markets. We link it to your clinical risk management (DCB0129 and ISO 14971) so it is one joined up system.
What we deliver
- Gap analysis against ISO 13485 with a prioritised plan
- Quality manual, procedures and document control
- Design and development controls for software
- Risk management aligned to ISO 14971 and DCB0129
- Supplier, CAPA and complaint handling processes
- Internal audit and certification readiness
Frequently asked questions
Do I need ISO 13485 for a Class I 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. Building it to ISO 13485 keeps you ready for higher classes and other markets.
Does ISO 13485 apply to software?
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Yes. Software as a medical device manufacturers use ISO 13485 alongside software lifecycle standards such as IEC 62304.
Can you start with a gap analysis?
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Yes. Most clients start with a gap analysis so they know exactly what is needed before committing to certification.
Related services
Talk to an Expert
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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.
Stacey Dudley
Chief Operating Officer
Suzanne Ash
Medical Device and Compliance Expert
Tom Falcon
Medical Device and Compliance Expert
Steve Robson
Clinical Safety Officer, Nurse
Dr Lizzie Marston
Clinical Safety Officer, GP
Mona Kapinga
Clinical Safety Officer, Pharmacist
Matthew Olsson
Clinical Safety Officer, Lead Trainer, Paramedic
Zara Mahmood
Clinical Safety Officer, Occupational Therapist
Shell Mcvey
Business Support Manager
Every engagement starts with a free 20-min scoping call, a conflict-of-interest check, and a plain-English summary before you commit.