ISO 13485:2003 standard sets out the requirements for a quality management system where an organization provides medical devices and related services.
Companies that wish to demonstrate their capacity to provide medical devices and related services that consistently meet customer and regulatory requirements are the ideal candidates for certification against ISO 13485:2003.
Boderm Laboratories has been inspected and granted with cGMP by Health Authorities and is officially registered in the European Directory of Medical Device manufacturers. Database available in all respected EU member states Health Authorities.
Boderm Laboratories is certified by highly qualify independent organisation of TUV Austria with ISO 13485:2003. TÜV Austria is a certification and inspection body with excessive certification and inspection reputation in International companies within our Industry.
Our Quality Assurance followed by all our staff involved in development and/or production of a Medical Device.
We are committed in compliance of all procedures and practices that will sustain a constant result within ISO and GMP standards.
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