Medical devices range from a low risk device such as a bandage to a high risk device such as implanted pacemakers.
Typical problems with medical devices include:
- deficiencies in labelling, instructions, or packaging
- defective components
- performance failures
- poor construction or design.
Investigations of medical device incidents may lead to regulatory and non-regulatory actions such as product cancellation, recalls, product improvement and user education.
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PageReporting adverse events (side effects to medicines and problems with medical devices) helps make medicines and medical devices safer for everyone.
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Reference materialLearn how we manage medical device adverse event reports.
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PublicationsYou can help by sharing our messages on social media, your website and around your workplace.
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PublicationsMDSU provides practical advice and information about medical device safety.
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