Kytogenics Pharmaceuticals Ltd has achieved registration to EN ISO 13485:2003 and CAN/CSA ISO 13485:2003, (Canadian Medical Devices Conformity Assessment System). These designations denote a company’s conformity to quality management standards for medical devices and were awarded to Kytogenics Pharmaceuticals Ltd. on March 08, 2005.
These standards specify requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet regulatory and customer requirements. The primary objective is to facilitate harmonized medical device regulatory requirements for quality management. The adherence to accepted management system standards and motivation and responsibility for maintaining registration to ISO 13485:2003 lies with the individuals within the company and affirms an ongoing commitment to quality assurance and improved quality management.
This universally accepted quality assurance designation specifically designed for medical device companies supplements ISO 9001 and has many of the same requirements, with additional requirements for process control, design control, retention of records, accountability, traceability, customer satisfaction and more.
Kytogenics' ISO registrations validate we are committed to quality and have the necessary processes in place to develop and manufacture products of the highest quality.Clients and customers can be confident that Kytogenics Pharmaceuticals Ltd. pledges to uphold the principles of our Quality Policy:
The management and staff are committed to:
- provide our internal and external customers a product that meets established requirements of safety and efficacy
- integrate quality principles and ethical values in everything we do
- motivate all employees to achieve excellence in their performance
- continuously pursue quality improvements of our products and processes.
Our certificates may be viewed here by downloading these links:
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