We help our customers in meeting the regulatory requirements. We know the MDR and IVDR regulations related to devices, accessories and software, as well as the quality system standard ISO 13485. We support companies with the changes required by the new regulations affecting both the quality system and the product documentation.

Our services include

• Device classification

• Product documentation according to MDR

• QMS according to standardin ISO 13485

• Risk Management

• Clinical Evaluation (CER)

• Pre-Audits

• Quality Manager as a service