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ISO 13485:2016 – Medical Devices Certification & Consultancy in Dubai, UAE

ISO 13485:2016 is the most frequently utilized international standard for quality control in the medical device sector. The ISO 13485:2016 standard, which was released by the International Organization for Standardization (ISO), is a practical way to satisfy all of the specifications for a Quality Management System in the medical device sector. This standard’s primary goal is to assist the regulatory functions inside the medical device industry with a standardized good management system requirement. For companies that manufacture medical devices, ISO 13485:2016 is a great system standard. The Quality Management System is satisfied using this method the vast majority of the time (QMS). The requirements for medical equipment in Europe, Canada, and Australia serve as the foundation for QMS compliance in various countries like Japan, Korea, and Brazil.
How Does the ISO 13485:2016 Certificate Advantage Your Organization?

You should probably have ISO 13485:2016 accreditation if you produce or sell a device with a Class II or higher risk classification and sell it outside of the United Arab Emirates. Additionally, ISO certification may improve your company’s profitability and increase your access to the market. Listed below are a few benefits of ISO 13485:2016

  • It is a requirement for entry into many important markets throughout the world and is the true standard for international medical apparatus QMS compliance. 
  • The fact that it requires commitment and effort to obtain the ISO 13485:2016 certification boosts your credibility with potential consumers.
  • An effective QMS system boosts productivity, raises product quality, and improves client relations in your company.
We will help you Apply ISO 13485:2016 or Update to ISO 9001:2015

We only work with firms that make medical and in vitro diagnostic gadgets, therefore we are familiar with the unique needs and manufacturing circumstances of the industry. Our team of skilled QA advisers has 10 years of experience and has assisted tens of thousands of medical device and IVD firms in obtaining ISO 13485:2016 certification. 

We can assist you here:

  1. To meet your needs and make sure you’re ready for a certification audit, we’ll thoroughly customize your ISO 13485:2016 quality program.
  2. Our ISO 13485:2016 project management and consulting teams collaborate closely with you to implement your QMS on schedule and within your budget.
  3. We can provide recommendations for reputable third-party testing and testing firms that focus on your employees.
Common Questions:
  • Can Nathan ISO Consulting issue our ISO 13485:2016 certificate?

The only notified bodies/registrars authorized to audit and certify your business to the ISO 13485:2016 standard are those that are licensed.

  • How long does it take to complete ISO 13485:2016 certification if there is no system in place?

Implementation typically requires 4-6 weeks for companies with more than 50 employees. Execution typically takes 6 to 12 weeks in larger firms with over 50 employees and/or multiple locations because there are more written processes required and more individuals involved. The execution process may also be extended by complicated manufacturing processes (such as sterilization, for example).

It may take at least 6 to 9 weeks to schedule an onsite audit in some markets, so it’s important to contact these associations as soon as you can to confirm their availability. The time frame for certificate issuance can also depend on the accessibility of Notified Body/Registrar auditors to audit and certify your organization.

Key Benefits of ISO 13485
  • Meet regulatory standards and show that medical device production is done safely
  • By entering more markets, you can increase gadget sales.
What further advantages can I expect?
  • Decreased operating expenses.
  • An improvement in stakeholder relations.
  • Legal observance.
  • Enhanced risk-taking.
  • Reputable business experience.
  • New market entryway.
  • Consumer contentment.
How is ISO 13485:2016 Structured?

The criteria of ISO 9001:2015 served as the foundation for ISO 13485:2016, which also shares a similar clause structure. For regulatory compliance in domestic and the majority of export markets, the ISO 13485:2016 standard, Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes, serves as the foundation. Having accreditation proves your dedication to fulfilling consumer demands.

Who Can Apply for ISO 13485:2016 Certification?

All manufacturers, suppliers, contract service providers, and distributors of medical equipment must comply with ISO 13485:2016 To lawfully manufacture and sell medical devices in some markets, ISO 13485 certification is insufficient on its own. Additional local regulatory certification is needed.

Get in touch with us

Do You Need a Consultant to Earn ISO 13485:2016 Certification? Please get in touch with us by phone or email if you want more information about ISO 9001:2015. We are happy to help you.

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