Facilitating your medical device certification
We pre-certify our medical gas systems. That’s how we simplify your certification processes when installing our medical compressor set-ups.
Surpassing medical ISO standards
Our medical gas equipment meets all requirements in safety and operating criteria. We design our products not only to comply with ISO certification. You know you will not compromise on quality, reliability or performance, because we surpass the strictest medical standards and regulations:
- Medical Devices Directive MDD 93/42/EEC
- European pharmacopeia
- EN ISO 7396-1
- ISO 14971
- Health Technical Memorandums HTM 02-01 and HTM 2022
Our PDp dry dust filters have been thoroughly tested and certified by an external laboratory, proving they can serve as bacterial filters.
Downloads
Certificates
- ISO 13485 Certificate 166.1 kB, PDF
ISO quality management system
Our quality management systems for designing, manufacturing, installing and testing medical devices meet the standards of ISO 9001, ISO 14001 and ISO 13485.
Dedicated medical facilities for local legislation
With dedicated medical production facilities in three countries - Belgium, the United Kingdom and the United States - we can meet differentiating local legislations.