ISO 13485 Certification
ISO 13485 is the internationally recognised quality management system standard for the medical device industry. It is required for regulatory approval and market access in the EU, Canada, Australia, Japan, and increasingly in India. Fusion Certification provides end-to-end QMS implementation support for medical device manufacturers.
What is ISO 13485 Certification?
ISO 13485:2016 specifies requirements for a quality management system for organisations involved in the design, development, production, installation, or servicing of medical devices and related services. Unlike ISO 9001, ISO 13485 has a mandatory compliance orientation rather than a continual improvement focus, reflecting the regulatory requirements of the medical device industry. It aligns with the EU Medical Device Regulation (MDR 2017/745) and IVDR (2017/746), Health Canada requirements, the Therapeutic Goods Administration (TGA) in Australia, and Japan's MHLW regulations. In India, the Central Drugs Standard Control Organisation (CDSCO) under the Medical Devices Rules 2017 increasingly references ISO 13485 as the baseline QMS requirement for manufacturing licence applications.
Who Needs It?
- Medical device manufacturers in India exporting to EU, UK, US, Canada, Australia, or Japan.
- In-vitro diagnostic (IVD) manufacturers and developers of laboratory equipment and reagents.
- Sterilisation service providers and contract manufacturers for the medical device industry.
- Software developers creating Software as a Medical Device (SaMD) requiring regulatory-grade QMS documentation.
- Businesses applying for CDSCO manufacturing licences where ISO 13485 QMS is required or recommended.
How Fusion Helps
Regulatory Mapping: We identify which regulatory frameworks (EU MDR, MDR India, Health Canada, TGA) apply to your device classification and map ISO 13485 requirements accordingly.
QMS Documentation: We develop the complete QMS documentation set — quality manual, device master record (DMR) structure, design and development controls, post-market surveillance procedures, and complaint handling processes.
Risk Management Integration: We help integrate ISO 14971 risk management requirements into the QMS design and development process.
Process Validation Support: We advise on process validation (installation qualification, operational qualification, performance qualification — IQ/OQ/PQ) documentation requirements.
Internal Audit: We conduct a clause-by-clause internal audit against ISO 13485 and applicable regulatory requirements, identifying non-conformances before the certification body assessment.
Frequently Asked Questions
Fusion Certification is an independent consultancy providing certification guidance, documentation, implementation and audit-readiness support. Final assessment and certification decisions are made by the relevant independent certification body or scheme authority.