Safety and quality are important in the medical device industry. ISO 13485 is a global standard operating in more than 30 countries. Manufacturers follow these standards to demonstrate the quality, safety, and reliability of the products they offer while providing assurance for consumers and regulators.
It is an international standard of quality system specific to medical devices and defined by ISO 13485. Originally established to assist with corresponding ISO 9001 standards, the standard has been revised for makers, particularly in health-relevant gadgets. It focuses on a risk-based approach to certification, which is used as one of the tools manufacturers can apply from product development through distribution — emphasizing that any firm should prioritize the safety of its products.
ISO 13485 addresses several important topics:
The ISO 13485 accreditation was designed especially for companies operating in the medical device sector. Companies that produce, develop, or market medical devices, as well as suppliers and service providers that assist the medical device industry
Achieving ISO 13485 certification is an investment in quality, customer trust, and brand reputation rather than just compliance. In addition to improving product safety and gaining a competitive edge in an overcrowded market, certified businesses find it easier to negotiate regulatory environments.
The cost of ISO 13485 Certification isn’t fixed as it depends on various factors such as
Typically, costs include an application fee and an Audit Fee. You can contact us at info@sqccertification.com to get a customized quote that fits your business requirements.
The cost of ISO 13485 Certification isn’t fixed as it depends on various factors such as
Typically, costs include an application fee and an Audit Fee. You can contact us at info@sqccertification.com to get a customized quote that fits your business requirements.
Choosing the right partner for ISO certification is essential. SQC Certification is the trusted partner for businesses seeking ISO Certification because of our expertise, professionalism, and commitment to client satisfaction. Our focus on customer satisfaction and commitment set us apart as the first choice for organizations looking for ISO certification.
ISO 13485 Certification is an internationally recognized standard for Quality Management Systems (QMS) specifically designed for medical device manufacturers. It ensures that companies meet regulatory requirements, maintain product quality, and prioritize patient safety throughout the medical device lifecycle.
ISO 13485 Certification is important for organizations involved in the design, manufacturing, installation, or servicing of medical devices. It is often required for regulatory compliance in the medical industry and is beneficial for any company seeking to ensure quality in medical device production.
Key benefits include improved product quality, regulatory compliance, increased market access, customer trust, and operational efficiency. Certification demonstrates the company's commitment to safety and reliability in medical devices.
ISO 13485 Certification is not legally mandatory; however, it is often a regulatory requirement in various countries. Certification can significantly enhance credibility and is essential for companies looking to expand into international markets.
ISO 13485 Certification is typically valid for three years. To maintain certification, organizations must undergo regular surveillance audits and a recertification audit at the end of the three-year cycle.
© 2024. SQC Certification Services Pvt. Ltd. – ALL RIGHTS RESERVED.
