What is the purpose of ISO 13485 certification for a US-based company?

The purpose of ISO 13485 certification for a US-based company is to improve their quality management systems, enhance compliance with regulatory requirements, and potentially expand market access by demonstrating adherence to internationally accepted quality standards.

How can ISO 13485 certification help in international markets?

ISO 13485 certification is globally recognized and accepted as a benchmark for quality management in the medical device industry. Certification can facilitate market access in other countries and regions where ISO 13485 is widely recognized, streamlining the regulatory process and enhancing the credibility of the company and its products in international markets.

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ISO 13485 Certification Consultants in USA

For an easy and smooth certification process, only a medical device regulatory consultant can help. Our step-by-step process, well-defined work methodology, and timely deliverables will surely benefit you. Team of Operon Strategist medical device regulatory consultancy plays a pivotal role in assisting medical device companies in achieving and maintaining compliance with ISO 13485 standards, which focus on quality management systems (QMS) specific to the medical device industry. Our presence and experience of working in many countries ensure the audit of your organization will be carried out as per the requirement of USA norms and you will get error-free deliverables.

What is ISO 13485?

ISO 13485 is a global standard developed by the International Organization for Standardization (ISO) that defines a Quality Management System (QMS) for the medical device and related services industry.

The standard ensures that organizations constantly meet the needs of their clients as well as any applicable regulatory requirements. It provides a global framework for the quality design, manufacture, and installation of medical devices.

ISO 13485 Certification

Like other ISO management system standards, certification to ISO 13485 is not a requirement of the standard, and organizations can reap many benefits from implementing the standard without undergoing the certification process. However, third-party certification can demonstrate to regulators that you have met the requirements of the standard. ISO does not perform certification.

How to Become Certified?

ISO 13485 is an international standard for quality management systems specific to the medical device industry. To become certified, organizations must understand the standard, conduct a gap analysis, develop and implement a compliant quality management system, perform internal audits, undergo external audits by an accredited certification body, and address any non-conformities. Achieving ISO 13485 certification demonstrates a commitment to quality and regulatory compliance in the medical device sector.

ISO 13485 Certification Consultants in USA

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Step By Step Process of the ISO 13485 Certification

Obtaining an ISO 13485 certification can be explained as a simple process. Follow these steps to get started:

Create a quality plan – certification starts with developing a quality plan to meet the requirements of the standard. Plan out how your quality system will function, what roles are required, and who will perform them.
Identify target markets and work toward compliance – determine where you would like to market your medical devices and establish compliance with other medical device regulations in those jurisdictions.
Implement design controls – design controls are needed from the beginning of the product development process and should be established and documented as early on as possible.
Establish document controls – train your staff to follow a consistent and uniform system for updating the QMS and maintaining its compliance with ISO 13485.
Build a CAPA system – along with Design Controls, CAPA forms the core processes of your QMS. Ensure that your CAPA procedures are well-defined and functional.
Schedule audits with Notified Bodies – Notified Bodies are organizations tasked with auditing medical device firms for ISO 13485 compliance. Certification audits are performed in two phases, with manufacturers expected to be completely compliant with the standard after the Stage 2 assessment.