ISO 13485:2016 Certification

ISO 13485:2016 Certification

Technological innovations in Medicine and Medical Devices require a certain level of certification [ISO 13845 Certification in Dubai], understanding of the regulatory environment, and what it implies for production and obligations. ISO 13485 Certification in UAE!

ISO 13485:2016 is the international standard for the quality management systems in the medical device industry, ISO 13485:2016 has been tested and proven. Companies that have achieved certification with CDG an ISO Company in Dubai can show proof to potential clients that they comply with best practices and with regulatory [ISO 13845 Certification in UAE] requirements. And along the way, your company will naturally enjoy better control over its processes, and continual improvement.

"ISO 13485:2016 Certification (ISO 13848 Certification in UAE) "


What is ISO 13485:2016?

ISO 13485:2016 is the latest internationally recognized quality standard, representing certain requirements for a comprehensive management system for the design and manufacture of Medical Devices throughout the world. [ISO 13845 Certification in UAE] Certification to ISO 13485:2016 requires its quality system to pass a 3rd party MDSAP audit. The ISO 13485:2016 supersedes earlier documents, including the 1997 EN 46001 and 46002.

ISO 13485:2016 is the latest version of ISO 13485. While it remains a standout document, this newest version aligns with ISO 9001:2008 meaning that 13485:2016 does not follow the high-level structure of Annex SL.

The Benefits of ISO 13485 Certification

The benefits of ISO 13485:2016 certification cannot be underrated. Medical companies of all sizes have understood the remits of significant savings in production cost and time, including other improvements that an efficient quality management system naturally brings. Here are a few benefits of ISO 13485

Improve Your Processes

Applying the ISO 13485 outline presents natural approaches to discover opportunities for improvements. The company will quickly identify and eliminate waste during production, avoid rework and minimize error. ISO 13485:2016 certification anchors efficiency and cost savings.

Better employee engagement

Employees are most times faced with improving their processes. With ISO 13485 Certification Dubai, not only will your employees often provide the best ideas, they will as well be much happier and more engaged in the success of the company. [ISO 13485 certification in Dubai] The ability of your employee to understand their roles in delivering quality products and services, the more engaged they are which leads to a sharp increase in productivity and efficiency.

Improve Your Company Image and Credibility

ISO remains the only internally recognized standard for quality in the medical device industry. Registration and Certification to this standard parades your company as one who considers quality first, and that you have a system in place to ensure quality products supply. With ISO 13485 Certification in UAE, your clients and customers are happy and solely committed.

Improve Customer Satisfaction

ISO 13485 anchors Quality Management Principles, which is the bedrock to ensure customer satisfaction. [ISO Certification in Dubai] These were achieved by assessing customer's needs and expectations. Customers know what they want and will not patronize a supplier that isn't certified. By ensuring the satisfaction of your existing customers, you automatically have them for life. This translates directly to increased revenue.

There are a lot more benefits of ISO 13485 certification, and this is why CDG the Providers of ISO Certification in Dubai and UAE is here to help you and encourage you to upgrade your certification and experience quality.

ISO 13485 Certification Process

ISO 13485 certification processes involve achieving a QMS based on the ISO 13485 requirements, and then hiring recognized and reputable ISO Certification Providers [CDG Certification Services] to approve your QMS as meeting the requirements of the ISO 13485 standard. Here are processes for ISO 13485 Certification:

  • Planning the Quality System
  • Meeting Regulatory Requirements
  • Documents, Records and Training
  • Implementing Design Controls
  • Management Processes
  • The Certification Audit

Sourcing of documents involves daunting steps, though companies can provide it internally. However, it is best to hire an ISO Certification Company in UAE to help. [CDG Certification Services]

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