ISO 13485:2016 certification helps organizations establish an effective Quality Management System for medical devices, ensure regulatory compliance, manage risks, maintain product quality, and demonstrate a strong commitment to patient safety and continual improvement.
The ISO 13485:2016 Specifies Requirements For A Quality Management System Where An Organization Needs To Demonstrate Its Ability To Provide Medical Devices And Related Services That Consistently Meet Customer And Applicable Regulatory Requirements. ISO 13485:2016 Can Also Be Used By Suppliers Or External Parties That Provide Product, Including Quality Management System-Related Services To Such Organisations. ISO 10993 Biological Evaluation Of Medical Devices, Evaluation And Testing Within A Risk Management Process, Is The Most Widely Used Standard For Assessing The Biocompatibility Of Medical Devices And Materials, And Provides A Framework For Determining The Appropriate Biocompatibility Steps For Planning A Biological Evaluation. GMP Good Manufacturing Practice (GMP) Is A System For Ensuring That Products Are Consistently Produced And Controlled
GROW WITH CERTIFICATION
Deliver consistent quality and exceed customer expectations.
Streamline processes and reduce waste to improve productivity.
Win more tenders and contracts with an internationally recognised certification.
Identify and control risks to ensure business continuity.
We understand your requirements and assess your readiness.
We help you build the required QMS documentation.
Implement the QMS in your organisation with our expert guidance.
Conduct internal audit and management review.
Our approved auditors conduct the certification audit.
Get ISO 9001 certified and grow your business.
Partner with GIC International and experience the confidence of working with a trusted global partner.
Global ISO Certification is a leading certification body committed to delivering internationally recognized
ISO standards and management system certification worldwide.
