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Published February 25, 2016, ISO 13485:2016 focuses on quality management systems and is recognised and used as a framework by the medical device industry regulators programs, including the Medical Device Single Audit Program (MDSAP).

The ISO 13485 standard provides manufacturers, designers, and suppliers to the medical device industry with a framework necessary to demonstrate compliance to regulatory requirements and mitigate risks to stakeholders.

It places more emphasis on risk-based thinking and decision-making while it also offers stronger intra-operability between the clauses and requirements.

Perhaps most importantly, it focuses on ensuring consistent quality, product safety and the sustainable success of your products or services, using competent and efficient quality management systems to support them. 

Persistent pressures from global competition demand that organizations continually improve your products, services, and business processes to remain competitive.

The objective of MDQMS ISO 13485:2016 is to facilitate harmonized and maintains medical device regulatory requirements and the requirements of the Quality management systems.

Medical Equipment’s are prone to any defect which causes injury to the public health and it is very dangerous.

Therefore ISO 13485:2016 provides and boosts a confidence and creates a credibility of the organization in the mind of the stakeholder, Directors and clients.

Key elements of the ISO 13485:2016 standard include

• Expands requirements for risk management and process-based decision-making.

• Increased attention on supply chain processes.

• Explicit requirements for software validation.

• Effective alignment of global regulatory requirements

Partner with us and gain the confidence of knowing you have a solid Medial Devices Quality Management System in place for medical devices.

Benefits of ISO 13485:2016 Application 

• Increase efficiency, cut costs and monitor supply chain performance

• Increase access to more markets worldwide with certification

• Demonstrate that you produce safer and more effective medical devices

• Outline how to review and improve processes across your organization

• Meet regulatory requirements and customer expectations

• An Obligatory requirement for CE Marking compliance

• Important for Tendering and International Trading