Our ISO 13485 certification services cover medical device QMS design, risk management, MDR 2017 alignment and certification audit support.
Home › Services › ISO 13485 Certification
ISO 13485 certification is the globally recognised quality management standard for the medical device industry. It shows regulators, hospitals and international buyers that your organisation designs, manufactures, stores, distributes and services medical devices under strict quality and regulatory control. PCN Global India Corporation helps medical device manufacturers, importers and suppliers in India implement ISO 13485:2016 and align it with CDSCO’s Medical Devices Rules, 2017 and global regulations.
ISO 13485:2016 – Medical devices – Quality management systems – Requirements for regulatory purposes – specifies QMS requirements for organisations involved in one or more stages of the medical device life cycle. Its central objective is to ensure devices are consistently safe and effective and that all applicable regulatory requirements are met.
| Particular | Details |
|---|---|
| Standard | ISO 13485 – Medical devices – Quality management systems – Requirements for regulatory purposes |
| Current Edition | ISO 13485:2016 (EN ISO 13485:2016 + A11:2021 in the EU) |
| Indian Regulation | Medical Devices Rules, 2017 (Fifth Schedule – QMS), administered by CDSCO |
| Related Standard | ISO 14971 – Application of risk management to medical devices |
| Applicable To | Medical devices, IVDs, components, sterilisation and related services |
| Certificate Validity | 3 years with annual surveillance audits |
Under the Medical Devices Rules, 2017, every manufacturer — domestic or foreign — must maintain a quality management system in line with the Fifth Schedule, which mirrors ISO 13485. CDSCO or state licensing authorities verify this QMS during audits for Class A–D device licences, and foreign manufacturers applying through their Indian Authorised Agent typically submit an ISO 13485 certificate as evidence of QMS compliance.
| Aspect | ISO 9001 | ISO 13485 |
|---|---|---|
| Industry | All sectors | Medical devices & IVDs |
| Focus | Customer satisfaction & continual improvement | Device safety, effectiveness & regulatory compliance |
| Risk Management | Risk-based thinking | Product life-cycle risk management (ISO 14971) |
| Documentation | Flexible | Extensive – medical device file, validation and traceability records |
| Regulatory Reporting | Not specific | Complaint handling, vigilance and advisory notices required |
🏭
Indian and foreign manufacturers of medical devices and IVDs of all risk classes.
🔧
OEM/ODM and private-label manufacturers producing devices for brand owners.
🧪
Suppliers of critical components, raw materials, packaging and sterilisation services.
🚢
Organisations handling storage, distribution and traceability of medical devices.
🛠️
Installation, servicing and repair companies for medical equipment.
🌍
Indian manufacturers targeting the EU, USA, Canada, Australia, Brazil and Japan.
Review of products, risk class under MDR 2017, existing processes and regulatory obligations.
Quality manual, procedures, medical device files, design and development files and supplier controls.
ISO 14971 risk management, process validation, sterilisation and clean-room controls where applicable.
Staff training, record generation, traceability, complaint handling and CAPA systems.
A full internal audit against ISO 13485 and MDR 2017 before the external audit.
Certification audits by an accredited certification body, with PCN support on-site.
ISO 13485 certificate issued, then used to support your CDSCO licence application on the SUGAM portal.
ISO 13485 certification typically takes 8 to 16 weeks, depending on the device class, scope (design, sterilisation, servicing) and documentation readiness. The certificate is valid for three years, with annual surveillance audits and a recertification audit before expiry.
PCN Global India Corporation combines ISO 13485 QMS implementation with CDSCO licensing — one team for your complete medical device compliance.
ISO 13485 certification confirms that a medical device organisation operates a Quality Management System meeting ISO 13485:2016 – the international standard for the design, development, production, storage, distribution, installation and servicing of medical devices.
The Medical Devices Rules, 2017 require manufacturers to comply with the quality management system set out in the Fifth Schedule, which is closely aligned with ISO 13485. In practice, ISO 13485 certification is expected for CDSCO manufacturing and import licence applications and by most buyers and hospitals.
ISO 13485 is based on ISO 9001 but is tailored to medical devices. It puts more emphasis on regulatory compliance, risk management across the product life cycle, design controls, sterile and clean-room controls, traceability, complaint handling and regulatory reporting, and it does not require continual improvement of customer satisfaction in the same way as ISO 9001.
Yes. EN ISO 13485 is the harmonised standard used to demonstrate QMS conformity under the EU MDR/IVDR, the US FDA Quality Management System Regulation (QMSR) incorporates ISO 13485:2016 by reference, and it is the basis of the MDSAP audit programme recognised by the USA, Canada, Brazil, Australia and Japan.
Typically 8 to 16 weeks, depending on the device class, whether design and development or sterilisation are in scope, and how much technical documentation and process validation is already in place.
Medical device and IVD manufacturers, contract manufacturers, component and raw-material suppliers, sterilisation service providers, importers, distributors and service/repair organisations involved in the medical device life cycle.
An ISO 13485 certificate is valid for three years, with annual surveillance audits and a recertification audit before expiry.
One of India's leading independent consultancy bodies providing compliance, certification, and regulatory services to international and domestic players in electronics, IT, chemical, and electrical sectors.