ISO 13485 – Medical Devices Certification

Dr Sulaiman Al Habib, Riyadh, Kingdom of Saudi Arabia – medical equipment groups signs up with ISO Saudi for training and implementation of ISO 13485 Medical devices certification.

With our local presence in Riyadh and Jeddah since 2005, ISO Saudi is the largest and the most efficient agency providing ISO 13485 advisory services within committed timelines of certification.

ISO 13485 has gained momentum ever since the requirement of SFDA Saudi Food and Drug Authority of certifying and listing all the medical products have been initiated.

These medical devices which are mostly exported or some of them being manufactured inhouse needs stringent quality controls and effective management system to ensure that the devices meet customer requirements and regulatory requirements.

ISO Saudi helps organisation dealing with Medical devices to write ISO 13485 Quality Manual, ISO 13485 Medical device file, Carrying out Risk assessment based on ISO 14971 and ISO 31001, Internal audit based on ISO 13485 standards, Validation of softwares based on the ISO 13485.

Located in Riyadh, Jeddah, Dubai, Muscat, Abu Dhabi and involved in Sales, Installation, Commissioning, Repair of Medical devices, do contact us to know more about the ISO 13485 certification for your organisation.

Drop us an email [email protected]