Crimson: Regulatory Updates



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Publications

Crimson has published an array of regulatory materials. Other information (such as our online library of labeling symbols) is available in the password-protected section of our website.

Article #1 in Risk Management Series — (published through Medical Products Outsourcing magazine) PDF 814K

"Risk-Based Validation of Multilingual Medical Devices" — (Reprinted with permission from Biomedical Instrumentation & Technology, a peer-reviewed journal by the Association for the Advancement of Medical Instrumentation. Visit www.aami.org to learn more about AAMI or to view BI&T's current issue.)
PDF 729K

Risk Management's "True Believers" — (published through Orthopedic Design & Technology magazine) PDF 729K

The Empirical Value of Risk Management — (published through Medical Device & Diagnostic Industry magazine) PDF 108K

Quality System Parity - Research Synopsis and White Paper — (published through Medical Products Outsourcing) PDF 72K

Case Study: Eliminate Translation Review — (Crimson research) PDF 64K

Case Study: Risk Management for Web Site Translation — (Crimson research)PDF 36K

Case Study: Multilingual Software Validation — (Crimson research) PDF 36K

GHTF Guidance Sparks Risk Management Concerns — (published through Orthopedic Design & Technology) PDF 192K

GHTF Labeling Guidance — (published through Multilingual Computing) PDF 164K

Quality Systems Drive Translation Industry Changes — Translation quality systems gain importance based on medical device influence

New GHTF Risk Management Guidance — (published through RAPS Focus magazine) PDF 304K

Labeling Language Requirements for EU Accession Countries — (Crimson research) PDF 216K

Labeling Language Requirements for the EU — (Crimson research) PDF 104K

Labeling Language Requirements for Asia — (Crimson research) PDF 112K

Electronic Labeling Update — (Crimson research) PDF 64K

Risk Management for Outsourced Services — (published in Medical Products Outsourcing magazine) PDF 112K

Vendor Outsourcing under ISO 13485 and ISO 14971 — (published through RAPS Focus magazine) PDF 120K

Critical Vendors: Health Canada/NB Definitions — (Notified Body guidance document) PDF 152K

Legal Guidance for MDD Language Requirements — (legal memorandum) PDF 536K

Regulatory Update: ISO 13485:2003 — (published through RAPS FOCUS magazine) PDF 632K

GHTF Labelling Guidance — PDF 56K

All documents are PDFs and will open in a new window. If a document fails to open, try right-clicking (PC) or Control+clicking (Mac), select "download link to disk" then open the saved file from your hard drive.

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