ISO 13485

Issuing ISO certificates for medical device companies per SFDA requirements.

SFDA Accepted

Accepted for manufacturers, warehouse (MDEL), and during SFDA MDMA review.

IAF Accredited

Your company will be listed on the IAF website under your certificate number.

Supported Medical Device Entities

Manufacturers

Wether your manufacturer is new or well established, we support developing QMS from Scratch or refine and close the gaps for current systems to comply with the ISO 13485 standards.

Warehouses

For stnadalone warehouses and those renting from others, we are experienced with SFDA expectations for the required QMS and how to audit and qualify the quality documentation for the ISO.

Authorised Representatives

The SFDA still requires an ISO1385-qualified quality system for the authorised representative offices. We develop the QMS, audit it, and issue the ISO 13485.

Distributors

Similar to warehouse qualification, distributors looking for an MDEL license need a quality system and ISO certification. We support your company with SFDA requirements until approval.

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.

FAQs

 

What is the timeline to issue ISO13485?

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 according to SFDA inspectors’ requirements.

Do you provide quality training?

Yes. We provide training on operating quality systems with accredited training certificates for your internal quality auditors.

What are the ISO13485 prerequisites?

A quality management system must be in place to be certified for ISO.

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 from an accepted and reputable certification body accredited by the International Accreditation Forum (IAF) and, therefore, accepted by the SFDA.

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