Mediktor is ISO 13485 Certified

In the medical devices industry, safety and quality are non-negotiable. We are committed to upholding the highest standards to ensure a trustworthy experience for both patients and professionals. With this certification, Mediktor reaffirms its capacity to systematically manage risk, enhance efficiency, and ensure regulatory compliance, thereby providing our clients with reliable and trusted healthcare solutions.

What is ISO 13485?

ISO 13485 is an international standard that sets the requirements for a quality management system (QMS) specific to the medical devices industry. Adhering to ISO 13485 underscores the importance of a comprehensive QMS covering a medical device's entire lifecycle, from design and development to production and commercialization. After an exhaustive evaluation process emphasizing risk management and risk-based decision-making procedures, we've achieved the high-level standards of this certification.

A Team Effort

A well-designed QMS provides a structured framework for consistent quality and continuous improvement. It aligns processes and policies across all departments, ensuring that every aspect of product development, from conception to delivery, adheres to high standards.?

Achieving ISO 13485 certification is a testament to the collective effort and dedication of all Mediktor teams. Every department played a vital role in this accomplishment, showcasing a unified commitment to quality and excellence. This milestone reflects Mediktor's collaborative spirit and unwavering focus on delivering superior medical solutions to our clients.

Mediktor is a Class I Medical Device?

Medical devices play a critical role in healthcare by enabling the pre-diagnosis and management of diseases and conditions, improving access to healthcare and enhancing the quality of professional time. Mediktor’s Class I classification indicates that we adhere to essential quality and safety standards. With the ISO 13485 certification, Mediktor reaffirms its commitment to high quality and ensures that all our processes and departments comply with internationally recognized standards.?

Next Steps

Building on the success of our ISO 13485 certification, Mediktor has also successfully passed the ISO 27001 audit, a globally recognized standard for information security management systems (ISMS). This accomplishment not only represents Mediktor's commitment to safeguarding sensitive information and data integrity but also reflects our proactive approach to maintaining the reliability of our AI solution and consistently evaluating its performance.