Certifications and quality
Quality is central to every activity at IBIS. From design to production, through to the marketing and servicing of radiological equipment, our processes are managed according to internationally recognized standards.
The certifications we have obtained attest to our ongoing commitment to ensuring reliability, safety, regulatory compliance and continuous improvement.
Operating in the medical device sector requires technical expertise, controlled processes and compliance with strict regulatory requirements.
For this reason, IBIS has adopted a certified Quality Management System that covers all company activities, from product design and development to production and after-sales service.
Periodic audits by the certification body ensure that the required standards are maintained and company processes are continuously improved.
ISO 9001:2015 Certification
ISO 9001:2015 certification confirms that IBIS’s Quality Management System complies with international requirements for the organization of business processes and customer satisfaction.
This standard ensures a structured approach to activity management, quality control and the continuous improvement of company performance.
Certificate: ISO 9001:2015
Certification body: IMQ
Certification expiry: 23 November 2026
ISO 13485:2016 Certification
ISO 13485:2016 certification is the international standard specifically for quality management systems in the medical device sector.
This certification attests that the processes adopted by IBIS meet the requirements for the design, production, placing on the market and servicing of radiological equipment for medical use, ensuring high levels of control and traceability.
Certificate: ISO 13485:2016
Certification body: IMQ
Certification expiry: 23 November 2026
CE Certificate and MDR Compliance
Compliance with Regulation (EU) 2017/745 on medical devices is a fundamental requirement for marketing IBIS products in the European market.
Our devices are developed and placed on the market in compliance with applicable requirements for safety, performance, risk management, traceability and post-market surveillance, ensuring compliance with current European legislation.
The CE marking demonstrates compliance with the standards required for use in the medical field and confirms IBIS’s commitment to quality, safety and reliability.
Certificate: CE 159/MDR
Certification body: IMQ
Certification expiry: 05 March 2029
Contacts
Via Cascina Bruciata, 3, 24068 Seriate – Bergamo
Do you need information for your company?
Contact the IBIS sales office. We respond to inquiries from distributors, importers, hospital groups, and professionals in the medical and radiology sectors.