RL 90/385/EEC
Conformity assessment of active implantable medical devices
 

What does the product offer?
 
EU conformity assessment according to RL 90/385/EEC and the Swiss Medical Devices Regulation with or without QMS certification in accordance with ISO 13485.

• Manufacturers of active implantable medical devices
• Marketers of active implantable medical devices
• Original Equipment Manufacturers (OEM) of active implantable medical devices

• Admission to EU market and CE conformity
• EU certificate
• Safe products
• Legal conformity and compliance with standards

• 3 years
• EU

• ISO 13485
• ISO 9001
• ISO 14001

Information
Karin Schulze