ISO 13485 Certification

Get ISO 13485 Certification

Want to get your organization certified for ISO 13458 standards? We’ve got you covered!

At International Quality Certification (IQC), we offer ISO 13485 certification audits performed by experienced and highly qualified auditors. Our team has extensive knowledge and experience in the medical device industry and is well-versed in the requirements of the

ISO 13485 standard for quality management systems.

During the audit process, our ISO 13485 certification auditors will thoroughly assess your organization’s quality management system to ensure that it meets all of the requirements of the ISO 13485 standard. This includes reviewing your organization’s policies, procedures, and processes and conducting on-site observations and interviews with relevant personnel.

Our team will then provide a detailed report of the audit findings, along with recommendations for any necessary corrective actions. We also offer ongoing support to help your organization maintain compliance with the ISO 13485 standard.

So, if you want to obtain ISO 13485 certification for your organization, contact us or give us a call to learn more about our certification audit services.

Our Best Features

Why Choose IQC?

Timely Services

After receiving our contract for certification, audits can be performed within 30 days of receiving the signed contract.

Guaranteed Results

We audit based on the ISO standards and do not have a quota to fulfill of nonconformances to document.

Long-term Relationship

After the initial certification audit IQC can perform your annual surveillance audits.

Ongoing Communication

After audits are completed feel free to contact us regarding any questions you may have-no cost obligation for this.

Looking For ISO 13485 Registration Services Online? IQC Can Help!

If you’re looking to register your organization as an ISO 13485 conformant, then you’re at the right place!

At International Quality Certification (IQC), we offer online ISO 13485 registration services to help medical device manufacturers register for this important standard. The standard is designed to help medical device manufacturers ensure that their products consistently meet customer and regulatory requirements and that they are safe and effective for their intended use.

As an independent and accredited certified body, our team of experts has extensive knowledge of the medical device industry and the requirements of ISO 13485. We use this expertise to guide our national and international clients through the online ISO 13485 registration process.

As an experienced registrar, our process begins with a quality documentation review and later determining the pre-assessment needs. Once done with our initial review, we’ll work with you to conduct a registration assessment ISO 13485 Certification audit to evaluate your current QMS and identify areas of non-conformities.

If your organization is successful in the ISO 13485 Certification audit (i.e., only after addressing the non-conformity findings in the audit report), you’ll be awarded an ISO 13485 certificate and will also be eligible to apply for our online ISO 13485 registration services. Once listed in the register, you’ll be able to demonstrate to your customers, regulators, and other stakeholders that your organization is committed to quality and patient safety.

So, whether you’re willing to get your first registration, or searching for a new registrar, contact us today to fill out a registration application!

Whether you are searching for a new registrar or are seeking your first registration, IQC will be of great service to you. IQC provides ISO 9001/ISO 14001/ISO 13485 certification services at a low cost.

Get In Touch

Contact us to learn more about our ISO registration and Certification Services

Contact us to learn more about our ISO registration and certification services that can assist you in improving your business. Our friendly and knowledgeable associates are ready to answer any questions you may have.