ISO 13485

ISO 13485 is a quality standard for organisations that design, develop, produce or service medical devices. It is intended to promote harmonisation in the medical device industry and set a basis for quality system regulations worldwide. All requirements of ISO 13485 are specific to organisations providing medical devices, regardless of the type or size of the organisation. Its primary objective is to facilitate harmonized medical device regulatory requirements.

What are the benefits of certification?

• Customer satisfaction - through delivery of products that consistently meet customer requirements as well as quality, safety and legal requirements
• Reduced operating costs - through continual improvement of processes and resulting operational efficiencies
• Improved stakeholder relationships - including staff, customers and suppliers
• Legal compliance - by understanding how statutory and regulatory requirements impact the organization and its customers
• Improved risk management - through greater consistency and traceability of products and use of risk management techniques
• Proven business credentials - through independent verification against recognized standards
• Ability to win more business - particularly where procurement specifications require certification as a condition to supply in a highly regulated sector

Who is ISO 13485 applicable to?

ISO 13485 contains requirements that are essential for any organization operating at any tier in the medical device and pharmaceutical supply chain. It is especially relevant to manufacturers that wish to demonstrate applicable regulatory requirements, and by organizations whose services support medical device manufacturers.

How can AEC help you to achieve ISO 13485 Certification?

AEC will assist your organization in ISO awareness training, documentation, implementation, internal auditing and overall process optimization as per ISO 13485 standard. AEC is a result oriented professional training and certification service providers, offering systematic approaches to improve quality and effectiveness of the system and enhance the productivity by offering systematic approaches. Our main objective is to help you and your organization improve profitability, through better utilization of all of your resources