Endocision Achieves ISO 13485:2016 and MDSAP Certification
Montreal, Quebec | July 22nd, 2024 – Endocision Technologies, a company developing minimally invasive cryogenic catheters for bronchoscopy applications, proudly announces the successful attainment of ISO 13485:2016 and Medical Device Single Audit Program (MDSAP) certification. This certification marks a significant milestone in Endocision’s path to the regulatory approval and commercialization of its technologies, and underscores its commitment to upholding industry standards in quality management and regulatory compliance.
ISO 13485 certification validates Endocision’s ability to consistently design, develop, manufacture, and distribute medical devices that meet customer and regulatory requirements. This standard is internationally recognized and demonstrates Endocision’s commitment to ensuring the safety and efficacy of its products throughout their lifecycle.
The MDSAP certification further demonstrates Endocision’s adherence to rigorous global regulatory requirements. This program allows for a single regulatory audit of a medical device manufacturer’s quality management system, ensuring compliance with the standards of multiple regulatory authorities, including those of the United States and Canada.
Anthony Sirgi, Director of Quality Assurance and Regulatory Affairs at Endocision, commented on the significance of this achievement: “Obtaining ISO 13485:2016 and MDSAP certification is a testament to our commitment to quality and regulatory excellence. These certifications validate our processes and procedures, ensuring that we deliver safe and effective medical devices that meet the stringent requirements of global regulatory bodies.”
About Endocision
Endocision is a medical devices company founded in 2019 that is developing minimally invasive cryogenic devices for diagnosis and treatment of lung diseases through bronchoscopy. Endocision is headquartered in Montreal, Quebec.
For more information about Endocision and its range of medical devices, please visit endocision.com.
Endocision’s ISO 13485:2016 and MDSAP certificate can be found at the following link.
