RL 98/79/EEC
Conformity assessment of in-vitro diagnostic medical devices
 

What does the product offer?
 
EU conformity assessment according to RL 98/79/EEC and the Swiss Medical Devices Regulation with or without QMS certification in accordance with ISO 13485.

• Manufacturers of in-vitro diagnostic medical devices
• Marketers of in-vitro diagnostic medical devices
• Original Equipment Manufacturers (OEM) of in-vitro diagnostic medical devices

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

• 3 years
• EU

• ISO 13485
• ISO 9001
• ISO 14001

Information
Karin Schulze