The International Accreditation Forum (IAF) has issued a new Mandatory Document for the Application of ISO/IEC 17021 in Medical Device Quality Management Systems (ISO 13485), the IAF MD 9:2011.
Presafe Denmark A/S has obtained an extension to its existing accreditation according to 17021:2011 and can now carry out certifications according to the new edition of DS/EN ISO 13485:2012.
"Variant Creutzfeldt-Jakob disease (vCJD) assays for blood screening, diagnosis and confirmation" has been added to List A of Annex II in the IVD Directive 98/79/EC.
