Technolution is certified according to ISO 9001: 2008 and ISO 13485: 2012. Our certification and our experience in working within our clients’ quality systems make the cooperation with certified businesses efficient.
Furthermore, Technolution is able to offer implementation of quality management systems in new businesses.
Technolution’s consultants are experienced in bridging regulatory demands, the creativity of the R&D departments and quality management.
ISO 9001 focuses on clients’ needs and continuous improvement of business performance through the requirement of continuous improvement of products, services, processes and systems.
ISO 13485 focuses on quality management in the development and manufacturing of medical devices. This includes requirements for risk management and documentation.
Technolution’s quality management system is also in compliance with the following standards:
|ISO 14971:2012||Medical devices – Application of risk management to medical devices|
|IEC 62366:2007||Medical devices – Application of usability engineering to medical devices|
|ISO 15378:2012||Primary packaging materials for medicinal products|
Scope of Technolution quality management system:
- Application of Technolution QMS (Quality Management System)
- Risk Management (ISO 14971)
- Business Processes (development and optimization of procedures, instructions and forms)
- Usability Engineering (DS/EN 62366)
- Verification and Validation