ISO 13485 certification for medical devices.
ISO 13485 is the quality management standard for medical devices, and a key step for regulatory approvals in many countries.
Medical Devices Quality Management
ISO 13485 covers design, production, storage, distribution and servicing of medical devices, with strong focus on risk management and traceability.
It is used by device manufacturers, component suppliers, distributors and service providers, and supports registrations with regulators such as SFDA.
- You make, assemble or distribute medical devices
- A regulator or distributor asks for ISO 13485
- You are preparing product registrations abroad
- You need traceability and risk management records
What ISO 13485 does for you.
Regulatory readiness
Supports registrations with health regulators.
Patient safety
Risk management throughout the product life cycle.
Full traceability
Every batch and component can be traced.
Market access
Distributors and hospitals trust certified suppliers.
From gap analysis to certificate.
The same proven steps for every standard, adapted to your size and industry.
- 01Gap analysis
We compare how you work today with the standard and give you a clear, written action plan.
- 02Documentation
Policies, procedures and records written for your business, not copied templates.
- 03Implementation & training
We help each department put the system into daily practice and train your staff.
- 04Internal audit
A full internal audit and management review, so nothing surprises you on audit day.
- 05Certification audit
We stand with you through the Stage 1 and Stage 2 audits by an accredited certification body.
- 06Surveillance & renewal
Ongoing support for yearly surveillance audits and recertification every three years.
Getting started is simple.
- A short call about your business, sites and number of staff
- Access to the people who run each department
- Any documents, procedures or records you already have
- A target date, if a client or tender needs the certificate by then
Certificates are issued by accredited certification bodies after their audit. We prepare you, help you choose a certification body and support you on audit day. Time and cost depend on your size and how much is already in place; you get both in writing after the first discussion.
Often combined with
Quality Management System
ISO 9001 is the world's most widely used quality management standard.
Explore ISO 9001 →ISO 27001Information Security Management
ISO 27001 is the leading standard for information security.
Explore ISO 27001 →ISO 14001Environmental Management System
ISO 14001 helps you control your environmental impact and meet legal requirements, a must for many export buyers.
Explore ISO 14001 →
Ready for ISO 13485?
Book a free consultation. We will tell you what it takes and what it costs.