Leader Group kick starts ISO 13485 Certification
Seven Steps for ISO 13485 Certification in Jeddah at LEADER HEALTHCARE
- Conducting Risk assessment based on the ISO Standards
- Preparation of Design control process documents
- Validation of Design and special process
- Writing Regulatory compliance records
- Following Medical equipment directive as per SFDA Saudi Food and Drug Authority
- Medical device file MDF file creation and review
- Process Internal audit in line with ISO 13485, Review with management
ISO 13485 Quality Management System certification Riyadh
SFDA has brought the Medical Device products for a level of understanding of the regulatory environment and implication it has on the regulatory obligations.
SFDA Saudi Food and Drug Authority KSA has constantly developing their local regulations based on the International Medical Device Regulator’s Forum – IMDRF model.
Already-existing regulations tend to be assessed by SFDA and/or accredited Certification Bodies.
The majority of these regulations have as common base the Quality Management System (QMS) and Risk management principles of ISO 14971 Risk assessment Medical device.
What is the ISO 13485 standard?
ISO 13485, Medical devices – Quality Management Systems – requirements for regulatory purposes, is an internationally recognized standard for organizations involved in the medical device industry. Companies are using compliance to this standard to obtain the certification of their Quality Management System. The primary purpose of the ISO 13485 standard is the Harmonization of the Medical Device regulatory requirements for Quality Management Systems.
Who can be ISO 13485 certified?
The ISO 13485 certification is a proof of Quality Management System compliance to the standard for organizations involved in the Medical Device manufacturing, distribution and servicing. This approach is not only followed by Medical Device factories and service industries but also supporting organizations such as Subcontractors, Suppliers, SFDA approved Representatives.
Achieving the ISO 13485 certificate from experts enhances the image of Medical device companies to which the standard can apply.
Located in Riyadh, Jeddah, Yanbu, Jubail, Dammam, Hofuf and looking for ISO 13485 Consultant, ISO 13485 Consultancy, ISO 13485 Compliance audit by expert drop an email to [email protected]