• Machinery Directive (98/37/AT)
  
  
• Low Voltage Directive (73/23/ AT)
  
  
• Gas Appliances Directive (90/396/ AT)
  
  
• Lifts Directive (95/16/ AT)
  
  
• Medical Devices Directive (93/42/ AT)
  
  
• IVD Directive (98/79/ AT)
  
  
• Construction Products Directive (89/106/AT)
  
  
• Pressure Equipment Directive (97/23/ AT)
  
  
• Simple Pressure Vessels (87/404/AT)
  
  
• Recreational Craft Directive (94/25/AT)
  
  

Additional Services

• Provide information on regulations and certification procedures
  
  
• Provide an expert opinion concerning classification of devices
  
  
• Device Classification Confirmation Services:
  It is imperative for the manufacturer of a product/device/apparatus/ piece of equipment to be placed on the European Market to firstly classify their products under EU 2007 57 EC MDD Directive , whether it is a medical device, an in-vitro diagnostic medical device, an active implantable medical device,  a low voltage product with or without electromagnetically compatibility, a radio and telecommunication apparatus, machinery,  cosmetics, personal protective equipment, pressure equipment, a construction product, a toy or any combination of such – it must be classified before it is to be regulated!
  
  
• Preliminary Assessment Services:
  AQA can provide an impartial 3rd party assessment of your quality management system and technical file(s) against the requirements of the Medical Devices Directive.
  
  
• Own Brand Labeling Services:
  AQA offers full Own Brand Labeling Services (OBL) to "Legal Manufacturers" that choose to apply their own name to products that have been designed and manufactured by an Original Equipment Manufacturer (OEM).
  
  
• Training
  
  
• Issue the certificates required for CE marking,
  
  
• Carry out EC examinations of design files
  
  
• Carry out EC type examinations:
  AQA has  the technical capability and knowledge of changing requirements to test when, where, and how you need it, to get your device to market faster than ever before.
  
  
• Carry out EC verifications
  
  
• Perform conformity tests to harmonized European standards or other standards
  
  
• Perform quality system audits in accordance with the annexes of the Directives
  
  
• Assess clinical, biological or scientific data, in consultation with hospital experts when required
  
  

• SEMDA – Southeastern Medical Device Association Meeting
  24 August 2010
  
  
• MDD Minnesota
  13-15 October 2010
  

• Medical Devices Brochure
  
  
• PED: EU Pressure Equipment Directive
  
  
• Article: Material Certification for PED Vendors
  
  
• Guidance for Classification of Medical Devices
  
  

• European co-operation for Accreditation
  
  
• New Approach Standardisation in the Internal Market
  
  
• EUROPA - European Commission - Enterprise - Regulatory policy - NANDO
  
  
• Guidance MEDDEVs - Medical Devices - Consumer Affairs
  
  
• European Commission - CE marking for professionals
  
  
• AQA International - CE Marking