Trusted ISO Provider by Industry Leaders
ISO 13485
Trusted ISO certification center for medical device companies, in accordance with SFDA requirements.
SFDA Accepted
Our certification bodies are accepted by the SFDA when issuing MDEL or MDMA licenses.
IAF Accredited
After we issue your ISO, your company name and certificate number will be listed on the IAF website.
SAC Accredited
Supported Medical Device Entities
Most Efficient and Trusted Provider
Why Choose PharmaKnowl For ISO 13485?
- Our ISO-compliant quality system addresses the deficiencies that SFDA inspectors look for.
- We specialize in ISO 13485 for medical devices and have an experienced team 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.
FAQs
What is the timeline for obtaining ISO 13485 certification?
It depends on the type of entity. For example, a warehouse takes 2-3 weeks, and a manufacturer takes 2-3 months.
Do you develop QMS?
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 in accordance with SFDA inspectors’ requirements.
Do you provide quality training?
Yes. We provide accredited training on operating quality systems for your internal quality auditors.
What are the ISO13485 prerequisites?
The main prerequisite is to have an established quality management system (QMS) that is operated by trained employees to undergo an ISO audit and receive the certificate.
Does SFDA accept PharmaKnowl to issue the ISO certificate?
PharmaKnowl and all Saudi-based ISO providers use international ISO certification bodies. PharmaKnowl will issue your certificate through an accepted, reputable certification body accredited by the International Accreditation Forum (IAF) and the Saudi Accreditation Center (SAAC), and therefore recognized by the SFDA.