ISO 13485 & Quality Systems
that meets SFDA Inspectors’ Expectations
ISO 13485
Most Efficient and Trusted Provider
Why Choose PharmaKnowl For ISO 13485?
- Our ISO-compliant quality system has additional sections that address the deficiencies that SFDA inspectors usually look for.
- We specialize in ISO 13485 for medical devices. Therefore, our team is experienced in your industry.
- Over the last few years, we have issued many certificates for local and international manufacturers based in Saudi Arabia, as well as famous distributors, warehouses, and authorized representatives in Saudi Arabia.
Medical Device Entities that must be certified in Saudi Arabia
FAQs
It depends on the type of the entity. For example, it takes 3 weeks for a warehouse and 2-3months for the manufacturer.
Yes. We develop quality management systems (QMS) for various entities and industries. Our systems comply with international standards such as ISO and PIC/S and are designed according to SFDA inspectors’ requirements.
Yes. We provide training on operating quality systems with accredited training certificates for your internal quality auditors.
A quality management system must be in place to be certified for ISO.
Yes. SFDA accepts our ISO certificates since they are accredited by the International Accreditation Forum (IAF).