ISO 13485 Certification – Overview
ISO 13485 is an International Standard for Quality Management System (QMS) of medical devices. ISO 13485:2016 compliance is crucial for gaining access to global medical device markets, especially in Europe. All medical device manufacturers in Europe must comply with the ISO 13485 standard to obtain the Conformité Européenne (CE) marking for their devices. Lately, the United States Food and Drug Administration (US FDA) has also proposed to amend its QMS requirements defined under Quality System Regulations (QSR) to harmonize with the ISO 13485:2016 compliance standards (Quality Management System Regulation [QMSR]).
Organizations complying with the ISO 13485 QMS requirements have the advantage of accessing other markets as well, since the Indian Medical Device Rules (IMDR) 2017, Korea Good Manufacturing Practices (KGMP), Brazilian Good Manufacturing Practices (BGMP), and Quality System Documentation (QSD) are similar to the ISO 13485 QMS requirements.
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The current version of ISO 13485 compliance came into effect in March 2016. The ISO 13485 QMS standard requires medical device manufacturers to fulfil its requirements at every stage of a device’s lifecycle. The key requirements for ISO 13485:2016 compliance are listed below:
- Documentation Requirements
- Management Responsibility
- Resource Management
- Product Realization
- Customer-related Processes
- Design and Development Processes
- Purchasing
- Production and Service Provision
- Control of Monitoring and Measurement
- Measurement, Analysis, and Improvement
Compliance with the current version of ISO 13485 QMS requirements is confirmed through audits performed by a Certification Body (CB) or Registrar. On passing the audit, an organization is certified for ISO 13485, which is valid for 3 years. Being ISO 13485 certified implies that the organization has fulfilled all its QMS requirements, and its product/s is/are safe and effective to be marketed. The organization must be re-certified every 3 years to maintain the ISO 13485:2016 compliance certification status.
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ISO 13485 Certification
- Medical device quality lifecycle management.
- Gap assessments and support for remediation.
- Mock audit support.
- Support for pre- and post-certification activities.
- Identification and support for region-specific QMS requirements, for example, MDSAP, 21 CFR 820, and IMDR 2017.
- Expertise in QMS projects for SaMD, wound dressing, drug device combination, IVDs, etc.
- Professionally qualified, trained, and experienced team members.
- Staff augmentation support in QA-RA roles, internal auditors, and trainers.
- End-to-end support, from establishing QMS to carrying out successful product registrations.
- Global presence to support on-site activities during ISO 13485 medical device conformity assessment by Notified Bodies (NBs).
- A vast network of Regulatory experts to cater to the needs of the market/customer.
