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Welcome to the world of excellence in medical device quality management through ISO 13485:2016 certification. ISO 13485:2016 is an internationally recognized standard specifically designed for organizations involved in the design, development, production, and servicing of medical devices.
Achieving ISO 13485:2016 certification demonstrates a commitment to upholding the highest quality and safety standards in the healthcare industry.
ISO 13485:2016 incorporates risk management principles to identify and mitigate potential hazards associated with medical devices.
The standard promotes a process-oriented approach to quality management, ensuring consistency and reliability.
ISO 13485:2016 includes provisions for post-market surveillance and monitoring of device performance.
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ISO 13485:2016 is an international standard that specifies requirements for a quality management system (QMS) for medical devices. It outlines the criteria for organizations involved in the design, development, production, installation, servicing, and distribution of medical devices to ensure the safety and effectiveness of these products. ISO 13485:2016 is particularly relevant for companies in the medical device industry, including manufacturers, suppliers, and service providers.
ISO 13485:2016 certification underscores a commitment to producing high-quality and safe medical devices. Organizations remain compliant with evolving regulatory requirements, reducing legal and financial risks. Certification facilitates access to international markets, enhancing business growth opportunities. ISO 13485:2016 certification enhances brand reputation and trust among healthcare professionals and patients.
ISO 13485:2016 provides a comprehensive framework for establishing, implementing, and maintaining a robust quality management system (QMS) tailored to the unique needs of the medical device industry.
Certification to ISO 13485:2016 ensures that organizations adhere to stringent regulatory requirements and industry standards, reducing the risk of non-compliance and product recalls.
With a focus on patient safety and product efficacy, ISO 13485:2016 certification instills confidence in stakeholders, including healthcare professionals and patients.
ISO 13485:2016 certification is often a prerequisite for accessing global markets, expanding the reach of medical device manufacturers.
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