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RL 93/42/EEC
Conformity assessment of medical devices
 

What does the product offer?
 

EU conformity assessment according to RL 93/42/EEC and the Swiss Medical Devices Regulation with or without QMS certification in accordance with ISO 13485.

Target groups
 
  • Manufacturers of conventional medical devices
  • Marketers of conventional medical devices
  • Original Equipment Manufacturers (OEM) of conventional medical devices
Customer's benefit
 
  • Admission to EU market and EC conformity
  • EU certificate
  • Safe products
  • Legal conformity and compliance with standards
Certificate validity
 
  • 3 years
  • EU
Possible combinations
 
 

Information
Karin Schulze


 
   

General trading conditions Sitemap Security
 ISO 9001 
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 Environment 1-2-3  
 OHSAS 18001 
 Valais Excellence 
 ISO/TS 16949 
 Global Standard for Food Safety (BRC) 
 IFS International Food Standard 
 IFS Logistic Standard 
 ISO 22000 
 FSSC 22000 
 GTP Coceral 
 FAMI-QS 
 BRC/IoP 
 BRC Global Standard Consumer Products 
 ISO 15378 
 DIN EN 15593  
 EN 15838 
 ISO 22716 
 ISO/IEC 27001 (ex BS 7799-2:2002) 
 ISO/IEC 20000-1 
 FSC COC 
 ISO 13485 
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 SA8000 
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 EN 16001 and ISO 50001 
 ISO 3834-2 
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 AQAP 2110 
 ISO 17712 
 EN 14065 
 EN 13549 
 MoU ECM (Entities in Charge of Maintenance for freight wagons) 
 RL 93/42/EEC 
 RL 90/385/EEC 
 RL 98/79/EEC 
 Pressure Equipment Ordinance SR 819.121 / Directive 97/23/EC 
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