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ISO 20417

ISO Publishes New Standards for Medical Device Manufacturers

The International Organization for Standardization (ISO) has published a new standard and a new guidance document to aid medical device manufacturers, providing guidance on...

Health Canada Announces Requirement for Medical Respirator Certification

Health Canada announced that, as part of its Interim Order (IO) authorization process, manufacturers of filtering facepiece respirators (FFRs) must certify their products for use...

How to Fix an Ailing Internal Quality Audit Program

By Vincent Cafiso Many of us in the quality profession are fully aware of and in most cases participate in our organization’s internal quality audit...

ISO Publishes New Guidance on Sterilization of Health Care Products

Ensuring medical devices are free of microbiological contamination requires microscopic attention to detect any sources of contamination, including those from the environment and health...

ASTM International Committee Invites Participation in Revision to Tissue Engineered Medical Products Standard

ASTM International’s committee on medical and surgical materials and devices (F04) invites all interested parties to participate in the revision of the terminology standard...

BSI Issues First UKCA Certificate Under the New UK Regulation for Medical Devices and...

BSI has announced that it has issued its first UKCA certificate under the UK MDR 2002 legislation for medical devices via its newly designated...

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