ISO 13485-Zertifikate für Medizinprodukte (SFDA)

Why Choose PharmaKnowl For ISO 13485?

Our ISO-compliant quality system is equipped with additional sections that address the usual deficiencies that SFDA inspectors usually look for.
We are specialized in ISO 13485 for Medical Devices. Therefore, our team is experienced in your industry.
We have issued many certificates for local and international manufacturers based in Saudi Arabia over the last few years. In addition to famous distributors, warehouses, and authorized representatives in Saudi.

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Share with us your company name, activity, and email to receive a quotation.

FAQs

How long does it take?

The whole process will take 2 - 3 weeks only.

Do you provide a quality system?

Yes, we provide you with a full quality system including policies, procedures, manuals, trackers, etc.

Do you provide training?

Yes, it is available.

What are the prerequisites?

A full-quality system that is built based on ISO13485 standards which we provide you with.

Is your certificate accepted by SFDA?

Yes, SFDA accepts it since it is issued by IAF accredited body.

Request a proposal

Share with us your company name, activity, and email to receive a quotation.

PharmaKnowl Consulting

Certified consulting office by SFDA for Medical Devices Consulting.

Our Services

Regulatory Affairs

Our SFDA consultants will design and implement innovative & visionary regulatory strategies to support your business. Providing product registration services, marketing approvals, new market entry projects, MA transfers, licensing, local manufacturing, and life cycle management.

Pharmacovigilance

Managing your pharmacovigilance function and post-marketing activities in Saudi Arabia, including QPPV Outsourcing, PV System, Development of PSMF / PSSF, Local literature monitoring, PV audits, and Training.

SFDA Consulting

Empower your decision-making by utilizing our experience in SFDA consultations, Saudi market research, and our insightful regulatory opinion. We guide, plan, and implement your regulatory projects in the Saudi Arabia market.

Commercial Support

OSince commercial and marketing modules vary in the Saudi market, directly impacting profit margins, we support the new access for international companies with insights and SWOT analysis on all available trade pathways.

Authorized Representative

We represent international biotech and medical device companies in Saudi Arabia. Providing full compliance with SFDA regulations, maintaining approvals, and post-marketing safety case submissions.

SFDA Registration

Leverage our advanced due diligence and gap analysis methods for your product files to achieve SFDA approval.
Our consultants are experts in product registrations, including drugs, biologicals, medical devices, food supplements, and others.