ISO 13485 - Approval basis for medical devices

In accordance with the EC directives 93/42/EWG, 90/385/EWG a certification through the QS systems ISO 9001 and ISO 13485 must be provided to obtain a conformity assessment. A positive result smoothes the way to the CE marking. This certification is needed by companies whose activities are connected to medical devices.

Benefits

• Based on ISO 9001 and can be combined with other certifications
• Legal requirements are adhered to
• Proof of quality and hygiene