Medical-device quality
ISO 13485 consultants.Helping you achieve certification.
Prepare your medical-device business for ISO 13485 certification. We help you review your quality system, clarify responsibilities and build the records and audit evidence needed for your agreed certification scope.
Free, no-obligation conversation.
The essentials
What is ISO 13485?
ISO 13485 sets quality management system requirements for organisations involved in medical devices and related services. It addresses the sector’s quality and regulatory needs.
Medical-device organisations and relevant suppliers or service providers seeking a quality management system aligned with their activities.
Official standard or scheme guidance ↗
Meet the consultants supporting UK businesses.
The right scope
Reflect your role in the device supply chain.
Quality controls
Review relevant processes and responsibilities.
Usable documentation
Connect procedures with real working practices.
Assessment evidence
Prepare through internal audits and review.
Practical support, in your world
From your starting point to assessment.
Understand your starting point
Review the scope and your existing system with a gap analysis.
Put the system to work
Address gaps, build usable evidence and complete internal audits.
Prepare for assessment
Get your team ready with assessment support. The approval decision remains independent.
Keep moving forward
Support throughout your ISO 13485 journey.
Useful answers
ISO 13485. Your questions answered.
How does ISO 13485 differ from ISO 9001?
ISO 13485 is designed for the medical-device sector and its quality and regulatory requirements. ISO 9001 provides a quality management framework across a wider range of sectors.
Does a certificate approve an individual medical device?
ISO 13485 certification concerns the quality management system. Product conformity and market-access requirements must be considered separately for the device and market involved.
Can you work with our existing quality system?
Yes. We can review existing procedures and records, identify gaps and agree the work needed for your chosen scope.
What affects the cost of ISO 13485 support?
Your activities, sites, existing system and preparation needs determine the consultancy scope. We provide a tailored quote. Budget separately for independent assessment and any scheme fees.
How long does preparation for ISO 13485 take?
Timing depends on your starting point, the work required, availability of evidence and assessment dates. A gap analysis helps establish a realistic plan.
Make an informed decision
Useful answers before you begin.
Your business. Your achievement.
Support towards your certification milestone.
From understanding the requirements to preparing for independent assessment, our team helps you build a working management system and confidence in your next step.
See client certification stories ↗Your next step
Let’s discuss your ISO 13485 requirements.
Share your business activities, current system and any customer or assessment deadline.
Talk it through: 0843 289 9434
Free, no-obligation enquiry. Consultancy is scoped around your business.