Providing consulting services for the implementation of
ISO 9001:2015,
ISO 13485:2012,
ISO 22716:2007s
tandards and for obtaining the certifications to these standards, pursuant to the provisions referred to in the Council Directive 93/42/EEC concerning medical devices, in cosmetic industry and health sector

Quality Management System/ Introducing the Quality Management System

Altagena Ltd is a company that has been providing consulting and auditing services for ISO 9001:2015 standard and for standards in the field of medical devices and cosmetic products (ISO 13485, ISO 22716 and certification for medical devices) for more than 10 years. Our expertise extends to the definition of business processes, input and output parameters, records confirming that the work has been performed, and strategic stakeholders, risk analysis of business operations and product production, and assistance in monitoring the required regulations. We offer creative views on solutions, with special emphasis on streamlining the process and accompanying documents.

Our main motto is

Quality Management System has to serve your purpose, and not the other way around

Our mission

To point to the benefits of introducing the quality management system even at smallest companies, to show that the quality management system is not just bureaucracy but that every business can benefit from introducing it, to provide creative solutions to clients so that they can manage the product/service quality efficiently and easily.

Our mission

To point to the benefits of introducing the quality management system even at smallest companies, to show that the quality management system is not just bureaucracy but that every business can benefit from introducing it, to provide creative solutions to clients so that they can manage the product/service quality efficiently and easily.

Producing technical documentation for medical devices certification

Five years’ experience in the field of auditing technical files for medical devices makes our business stand out in our market as the only consulting company with such experience.

Our vision

To be recognized as a consulting company that meets and overcomes, efficiently and with creativity, the challenges our clients face when implementing the quality management system, and, at the same time, trying to minimize formalism as much as possible.

Our Vision

To be recognized as a consulting company that meets and overcomes, efficiently and with creativity, the challenges our clients face when implementing the quality management system, and, at the same time, trying to minimize formalism as much as possible.