Quality is our priority
Certifications
ISO 13485, CE marking and Certificate of Free Sale.
Medical-device compliance information must be verified against the applicable, current documentation for each product. CE marking and quality-management information are presented for identification, without publishing certificates.
As a manufacturer of medical technology and electronics, we provide our customers with first-class quality and excellent products.
Certifications
Quality management systemISO 13485
IG Medical works to a quality management system for medical devices in accordance with EN ISO 13485:2016.
Affixed to the deviceCE marking
CE marking indicates that a device conforms to the applicable European requirements.
For export and registrationCertificate of Free Sale
A Certificate of Free Sale confirms that a device is freely sold in its country of origin. Importing authorities commonly require it during product registration.
Regulatory informationEU Declaration of Conformity
Device-specific conformity documentation is maintained according to the requirements applicable to the individual product.