Open Daily: 10am - 10pm | Alley door pickup 10am - 7pm 3038 Hennepin Ave Minneapolis, MN
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  • Open Daily: 10am - 10pm
    Alley-side Pickup: 10am - 7pm

    3038 Hennepin Ave Minneapolis, MN
    612-822-4611

Open Daily: 10am - 10pm | Alley-side Pickup: 10am - 7pm
3038 Hennepin Ave Minneapolis, MN
612-822-4611
Signal Management in Medical Device Vigilance: From Complaints and Trends to Risk File Updates and Field Safety Action

Signal Management in Medical Device Vigilance: From Complaints and Trends to Risk File Updates and Field Safety Action

Selim, Hafez

Paperback

Series: Medical Device Safety

Business GeneralMedical Reference

ISBN13: 9798175197588
Publisher: Independently Published
Published: Sep 18 2026
Pages: 258
Weight: 1.33
Height: 0.54 Width: 8.50 Depth: 11.00
Language: English

The first book on signal management written for medical devices.

Device companies receive complaints, code them, decide what is reportable, and file on time. What most of them lack is an owner for the question that connects all of that work: what does this pattern mean, and what must change because of it? Pharmacovigilance answered that question years ago with a named discipline. Device regulation never did. EU MDR Article 88 asks for trend reports, ISO 14971 asks for post-production information to flow into the risk file, and ISO 13485 asks for complaints to be investigated, but none of them tells a vigilance specialist how to recognize that three fractures at a new location matter more than ninety cosmetic complaints, or how to defend a decision not to act when an auditor reads the record two years later.

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