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ISO 13485 Certifications

Original price was: ₹17,000.00.Current price is: ₹8,500.00.

Category: ISO Certification Services Tags: Certifications, ISO, ISO 13485

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ISO 13485 Certificate

The ISO 13485 certificate is a certification that confirms a company’s compliance with the requirements outlined in the ISO 13485 standard. This standard specifies requirements for a quality management system (QMS) for organizations involved in the design, development, production, installation, and servicing of medical devices and related services.

Obtaining ISO 13485 certification demonstrates that a company has established and maintains an effective quality management system tailored specifically to the medical device industry. It signifies a commitment to consistently meeting customer and regulatory requirements, enhancing customer satisfaction, and ensuring the safety and efficacy of medical devices.

The certification process typically involves an assessment by a third-party certification body. This assessment evaluates the organization’s QMS against the requirements of ISO 13485. If the organization meets the criteria, it is issued an ISO 13485 certificate, which is valid for a certain period, usually three years, subject to regular surveillance audits to ensure continued compliance.

Having an ISO 13485 certificate is often a requirement for companies involved in the medical device industry, as it can enhance their credibility, competitiveness, and access to global markets. It demonstrates a commitment to quality and regulatory compliance, which is crucial in a highly regulated sector like healthcare.

ISO 13485 is for quality management system for medical devices this certificate is applicable for manufacturer, supplier and traders of medical devices. If you are designing, manufacturing, supplying, trading of various medical devices like syringe, medical testing equipment, bone cutter machine, medical equipments etc, you are eligible to get this certificate

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