Quality and Compliance Services
Importance of ISO 13485 consulting Saudi Arabia
ISO 13485 is the international standard for quality management systems in the medical device sector. It is a prerequisite for manufacturers and distributors of medical devices and supplies.
It covers the entire life cycle of devices, from design and development to production, installation, and service, and aims to ensure that medical devices are safe and effective for their intended use.
Compliance with these standards is often a requirement for regulatory approval for medical devices, as they provide a framework to ensure that products meet SFDA regulatory requirements as well as customer needs.
What Our Quality and Compliance Service Covers?
ICC’s quality and compliance services include providing ISO 13485 consulting in Saudi Arabia, providing technical and organizational support to build a quality management system compatible with medical device operations, and ensuring that medical devices comply with internationally required quality standards, as well as locally with SFDA.
Who Needs ISO 13485 and QMS Support?
Medical device manufacturers, importers, and distributors need ISO 13485 support and a quality management system, whether they produce simple, low-risk devices, such as medical thermometers and disposable gloves, or complex, high-risk devices, such as dialysis machines and MRI machines.
Our Quality Compliance Process
Steps to develop a quality and compliance system include:
- Evaluate compliance by analyzing the current situation compared to ISO 13485 requirements.
- Preparing the necessary documents.
- Training employees on quality requirements.
- Internal auditing that conducts internal reviews to ensure compliance.
SFDA Inspection and Ongoing Compliance Readiness
The ISO 13485-compliant quality and compliance system ensures medical device quality compliance with safety and quality standards, ensuring readiness for inspection by the SFDA.
Why Choose ICC for Quality Compliance?
ICC provides QMS consulting services, ensuring the establishment of a quality system compliant with SFDA regulations, ensuring that medical devices, whether low-risk or high-risk, comply with these regulations and ISO 13485 standards, ensuring product safety and enhancing customer and regulatory confidence.
We also provide registration services with the SFDA, licensing, and full representation of companies before the SFDA.
Frequently Asked Questions
Does ICC issue the ISO 13485 certificate?
ICC does not issue ISO 13485 certification, but rather establishes a quality and compliance system that complies with ISO 13485 standards, to ensure that the certification is issued by the donor and that its requirements are met.
Can ICC prepare an existing QMS for SFDA inspection?
Yes, ICC can equip a quality system considering SFDA inspection readiness, meeting ISO 13485 requirements while complying with the updated regulations of the SFDA regarding the safety of medical devices.
