ISO 13485 Certificate accepted by SFDA
Fast & Reliable ISO with Guidance on SFDA Expectations. We build Quality Systems for the MedTech Industry in Saudi Arabia
ISO 13485
Your company will be listed on the IAF website under your certificate number.
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 look for.
- We specialize in ISO 13485 for medical devices; our team is experienced in the MedTech industry.
- Our team has been developing QMS and certifying local Saudi manufacturers, warehouses, and other entities for many years, including top distributors and well-known manufacturers in Saudi Arabia.
Supported Medical Device Entities
FAQs
It depends on the type of entity. For example, a warehouse takes 2-3 weeks, and a manufacturer takes 2-3 months.
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).