ISO 14971 Certification : medical devices Risk management system.

✔️ WHAT IS ISO 14971 Certification ?

ISO 14971 Certification is an international ISO standard for medical device risk management for more than 21 years. If you want to export your medical devices in the US or European country, ISO 14971 Certification will become an absolute necessity in your quest to obtain FDA clearance / approval for your device or CE-Marking certification under the EU-MDR or IVDR.

The Role of ISO 14971 Certification

Fortunately, national governments have not created their own unique guidelines-telling you how to perform risk-management. Instead, they defer to ISO 14971 Standard, the global standard for medical device risk management. If you are just getting started implementing risk-management for your organization, get the ISO 14971:2019 Certification. Which provides support to implementing risk management. Both are copyrighted documents & you can purchase them online . 

The intent of ISO 14971 Certification is to define a standard process for identifying risks associated with medical-devices at all stages in a device’s life cycle, from product-design to procurement to production and post-market use. In all cases, the goal is to evaluate, analyze, control, and monitor the risks-associated with each life-cycle stage.

ISO 14971 Certification Regulatory Compliance Process

ISO 14971 Certification Regulatory compliance process– focuses on the application of risk management to medical devices. Requiring the Implementation of management policies, procedures and practices. Core Compliance define the risk-management-process, that includes a framework of requirements and road map to compliance that includes: 

✓ Establish-Framework 
✓ Establish Intended Use
✓ Identify Hazards/issue
✓ Define the Hazards 
✓ Estimate Risk
✓ Evaluate the identified Risks (Develop Matrix chart)
✓ Risk Control
✓ Risk management report
✓Product & Post Production

Advantage of ISO 14971 Certification in organization -

  • To have better planning and framework of risk-management
  • To assure product development with desired quality and safety-standards
  • Integration of risk-management into an existing Quality Management System
  • To demonstrate compliance to regulations
  • To have structured approach while implementation
  • To learn the overview of risk-management activities.

What topics does ISO 14971 :2019 Certification cover?

At the highest level, ISO 14971:2019 Certification covers the following topics with regard to medical device risk management:

👉 Context of the organization
👉 Leadership
👉 Support
👉 Operation
👉 Performance-evaluation
👉 Improvement


How to Get Started with ISO 14971 Certification consultancy? QMCS INDIA ISO Certification Consultants Can Support!

ISO 14971 Certification consultancy  role is to assist you and lead your business on the path to successful ISO certification. Our qualified ISO 14971 Certification Consultants check your Risk-management for medical devices management system and assist you to enhance it, strengthening the weaknesses through ongoing support and consultation. 

ISO 14971 standard is designed to be flexible & is hence achievable by any-organization regardless of its size, scale, or revenue. QMCS INDIA consultants will support you transition to the most appropriate Risk management for medical devices management system for your business, saving both resources and time. We minimize the hassles in achieving compliance of your ISO 14971 Certification with our services like gap analysis, readiness reviews, and internal-audits.

Our ISO 14971 Certification Consultancy Services

If you are new to ISO 14971 Certification, our consulting services can support you through all the stages of preparation. Our ISO 14971 Certification consultants can do on-site inspections, hazard and opportunity-assessments, and employee interviews to get an overall view of your quality management program.

We, at QMCS India offer leading Risk management for medical devices consulting services to help you develop a fully compliant ISO 14971 Certification. Our Consultancy services start with premium consultation where we support you to understand the specifications of the ISO 14971 standard, the need for an ISO standard policy and defined objectives, crucial documentation requirements, and the ISO 14971 Certification implementation process. Then, we do a gap analysis or pre-assessment of your existing management systems to uncover any shortcomings against ISO 14971 requirements.

Subsequently, we provide you with necessary assistance to amend the shortcomings and implement an improved ISO 14971 Certification that is 100% ready for ISO certification.

Our ISO 14971 certification consultancy  services also include certification readiness review. This is especially useful for organizations that have already established the ISO 14971 standard and are ready with documentation-requirements, but would like final assurance from ISO experts. Our ISO 14971 consultants perform a final assessment of their QMS and confirm its compliance and readiness for the certification.

Our ISO 14971 certification consultants also assist in conducting thorough internal-audits at periodic intervals to ensure that your QMS procedures and its comprehensive documentation are continually ISO compliant. QMCS INDIA also provide remote auditing services for ISO 14971 that need to get certified quickly.

Our consultation and dedicated support are intended to get your business ISO 14971 certified within the determined time-period and in the most cost-effective way. Our ISO 14971 consultants strive to make your journey as uncomplicated as possible with a customized approach. We not only assist you to achieve the certification painlessly but also make sure that your business derives maximum benefits from it.

Why Hire ISO 14971 Certification Consultants from QMCS INDIA ?

✅ Cost effective – We deliver a lean, custom fit ISO compliant-management system, saving significantly on the often overlooked, but usually most expensive part of ISO compliance- the implementation stage.

✅ Speed – Everybody knows how lengthy an ISO certification process is! It is difficult to be motivated and focused if ISO certification takes too long. Don’t worry! QMCS INDIA can support you get ISO 14971 certification within 90-days, or often in less time than that!

✅ Resources to obtain and maintain certification – ISO compliance does not need to cost a lot to maintain! We minimize the need for internal-resources with a lean and compliant ISO quality consulting approach.

✅ Ongoing support – QMCS INDIA can support you manage ongoing compliance on your own, or you can team up with us. Our personalized ISO certification services include monitoring and internal-audits as well. Our ISO 14971 Certification consultant can monitor your medical device risk management  system to ensure consistency, improvement, and compliance. our team can also support in making it compliant with future updates to the ISO standard a cinch. 

✅ Resources to obtain and maintain certification – ISO compliance does not need to cost a lot to maintain! We minimize the need for internal resources with a lean and compliant ISO quality consulting approach.






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