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ISO 13485:2016 Compliance

Overview

Overview

ISO 13485 is an International Standard for Quality Management System (QMS) for medical devices. ISO 13485:2016 compliance is crucial to gain access to global medical device markets, especially in Europe. All medical device manufacturers in Europe must comply with the ISO 13485 standard to obtain CE marking to market their devices. Lately, the US FDA has also proposed to amend its QMS requirements defined under Quality System Regulations (QSR) to harmonize with ISO 13485:2016 compliance standards (Quality Management System Regulation (QMSR)). Organizations complying with ISO 13485 quality management system requirements have the advantage of accessing other markets as well, since Indian Medical Device Rules (IMDR) 2017, Korea Good Manufacturing Practice (KGMP), Brazilian Good Manufacturing Practices (BGMP), and Quality System Documentation (QSD) are similar to ISO 13485 quality management system requirements.

The current version of ISO 13485 compliance came into effect in March 2016. The ISO 13485 quality management system standard requires medical device manufacturers to fulfil its requirements at every stage of the device life cycle. The key requirements for ISO 13485:2016 compliance are enlisted below:

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  • 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 quality management system requirements is confirmed through audits performed by a Certification Body (CB) or Registrar. On passing the audit the organisation is certified for ISO 13485 which is valid for 3 years. Being ISO 13485 certified implies that the organization has fulfilled all QMS requirements, and the product/s is/are safe and effective to be marketed. The organization must be re-certified every 03 years to maintain the ISO 13485:2016 compliance certification status.

Freyr’s Regulatory experts will guide you meticulously in every step of the device life cycle to ensure seamless implementation ISO 13485 quality management system requirements

Freyr Expertise and Advantages
Expertise

Freyr Expertise

  • Medical device Quality Management System (QMS) management lifecycle
  • Gap assessments and support for remediation
  • Mock audit support
  • Support for pre and post-certification activities
  • Identification & support for region-specific QMS requirements example MDSAP, 21 CFR 820, IMDR 2017
  • Expertise in QMS projects for SaMD, Wound dressing, Drug device combination, IVDs, etc.
Advantages

Freyr Advantages

  • 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 successful product registrations
  • Global presence to help on-site support during ISO 13485 medical devices conformity Assessment by Notified Bodies
  • A vast network of Regulatory experts to cater to the needs of market/ client