Don't Worry, You're Safe Now

Don't Worry, You're Safe Now

Safety and quality are non-negotiables in the medical devices industry. Regulatory requirements are increasingly stringent throughout every step of a product’s life cycle, including service and delivery. Increasingly, organizations in the industry are expected to demonstrate their quality management processes and ensure best practice in everything they do.


What is the ISO 13485 standard?


ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry. It has recently been revised, with the new version published in March 2016.


What is a medical device?


A medical device is a product, such as an instrument, machine, implant or in vitro reagent, that is intended for use in the diagnosis, prevention, and treatment of diseases or other medical conditions.  


Who is ISO 13485 for?


ISO 13485 is designed to be used by organizations involved in the design, production, installation, and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.


Certification to ISO 13485


Like other ISO management system standards, certification to ISO 13485 is not a requirement of the standard, and organizations can reap many benefits from implementing the standard without undergoing the certification process. However, third-party certification can demonstrate to regulators that you have met the requirements of the standard. 


Why was ISO 13485 revised?


ISO 13485 was finally revised after 13 years and has many significant changes. The three main reasons for the updates are: 

  • The medical device regulatory environment has evolved since 2003.

  • Risk management and risk-based decision-making processes have become the main focus of the entire medical device industry.

  • ISO 13485:2016 no longer aligns with the current version of ISO 9001 but rather aligns with the previous revision, ISO 9001:2008.

ISO 13485:2016 is designed to respond to the latest quality management system practices, including changes in technology and regulatory requirements and expectations. The new version has a greater emphasis on risk management and risk-based decision making, as well as changes related to the increased regulatory requirements for organizations in the supply chain.


Why do you need to get ISO 13485 certified?


Whether you are looking to operate internationally or expand locally, ISO 13485 Certification can help you improve overall performance, eliminate uncertainty, and widen market opportunities. Companies with this certification communicate a commitment to quality to both customers and regulators.

  • Increase access to more markets worldwide with certification.

  • Outline how to review and improve processes across your organization.

  • Increase efficiency, cut costs and monitor supply chain performance.

  • Demonstrate that you produce safer and more effective medical devices.

  • Meet regulatory requirements and customer expectations.  

ISO 13485 is in part designed to produce a management system that facilitates compliance to the requirements of customers and global regulators. Benefits can be reaped from being both 9001 and 13485 certified because 9001 focuses on business aspects not found in 13485 that are good for all businesses. If the proper management system framework is in place it should facilitate the identification and implementation of country-specific requirements for the management system of medical device manufacturers. ISO 13485 is not specific enough to contradict country-specific requirements and should serve as a baseline management system for all.


ISO 13485 Consultation in Jordan


If you are looking for ISO 13485 consultation in Jordan, you are at the right place! AAC MENA is one of the best providers to obtain the ISO 13485 certificate for your industry in Jordan at an affordable price. AAC MENA is known for ensuring customer satisfaction and business improvement.




As a leader in consultation services, AAC MENA offers unrivaled experience and expertise in ISO 13485 requirements. Our presence in the Middle East and harmonized approach give you access to the largest independent network of consultants and advisory services in the region.

To discuss your ISO 13485 requirements, contact us today. 

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