Download our latest brochures to learn more about the services and expertise we can provide and the benefits this can bring to your organization.
Brochures
Medical Devices Regulation guidance
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Medical Device Documentation Submissions Best Practice Guidelines >
Best Practice Guidelines: Everything you need to know to successfully submit technical documentation for certification.
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Medical Devices Regulation Documentation Best Practices Guidelines >
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Medical Devices Regulation Mapping Guide >
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MEDDEV 2.7.1 Rev 4: Top ten changes >
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MDR Conformity Assessment Routes >
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Readiness Review >
In Vitro Diagnostic Regulation guidance
ISO 13485 Medical Device Quality Management System guidance
Medical device technologies
Download our medical device technology brochures.
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Active Medical Devices >
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Active Implantable Medical Devices >
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Devices utilizing animal tissue >
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In Vitro Diagnostics >
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Medical devices with ancillary medicinal substances >
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Microbiological testing >
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Microbiology assessment planning guide >
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Mobile Devices >
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Ophthalmic Devices >
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Orthopaedic and Dental Devices >
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Reclassification of spinal devices >
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Software as a Medical Device >
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Sterilization assessment guide >
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Vascular Devices >
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Woundcare >
Global market access
Download our global market access brochures to find out more about BSI’s role in product and system certification.
