Quality Assurance

Quality Assurance

MD Biosciences is fully committed to quality and customer satisfaction. The company has achieved ISO 9001:2000 and EN 46001 certification from SGS, a leading inspection, verification, testing and certification company.

ISO 9001:2000
Customers increasingly demand from their suppliers to comply with the highest product and service quality requirements. MD Biosciences assures its customers that its business will meet their needs now and in the future.

ISO 9001:2000 is based on eight quality management principles:
  • customer focus
  • leadership
  • involvement of people
  • process approach
  • system approach
  • continual improvement
  • fact based decision making
  • mutually beneficial supplier relationships

EN 46001
MD Biosciences is certified EN 46001 by SGS, the leading certification body for medical devices. EN 46001 is a certification of a quality management system specifically for medical devices, and is advantageous, and in many cases essential, for medical companies which export their products to the global market.

SGS undertakes assessments and certifies manufacturers of medical devices under UKAS and CMDCAS and helps meet the relevant regulatory requirements in Europe, USA, Canada and Australia.

Click here to download a copy of the MD Biosciences certificate.