ISO 13485 Certification
Medical Devices Quality Management System
ISO 13485 specifies requirements for a quality management system specific to the medical device industry. It is applicable to organizations in any stage of the life cycle of a medical device.
How Certsure helps with ISO 13485
Certsure Certification is a consultancy based in Lucknow, working with organisations across India. We help you understand the requirements, close the gaps and get ready for assessment — gap analysis, documentation, implementation support, training, internal audits and support during the external audit. The certificate itself is issued by an independent, accredited certification body after its own audits.
Not sure whether ISO 13485 is the right fit? Read how to choose the right ISO standard or ask our team.
Benefits of ISO 13485 Certification
Regulatory Compliance
Market Access
Patient Safety
Quality Traceability
Stakeholder Confidence
Risk Management
ISO 13485 process, step by step
- Application
- Regulatory Landscape Review
- Gap Analysis
- QMS Documentation
- Implementation Support
- Stage 1 Audit
- Stage 2 Audit
- Certification decision by the certification body
Timelines depend on your organisation's size, the scope and how much of the system already exists. Read how to prepare for an ISO audit.
Documents typically required
We provide a checklist tailored to your organisation. Commonly needed:
ISO 13485: frequently asked questions
Is ISO 13485 mandatory for medical device manufacturers?
Does ISO 13485 replace ISO 9001?
Who issues the ISO 13485 certificate?
How long is ISO 13485 certification valid?
How much does ISO 13485 certification cost?
Request a free ISO 13485 consultation
Tell us about your organisation and we'll explain the requirements, timeline and next steps — no obligation.