Broschüren Medizinprodukte
Deutsche Version | English Version |
Richtlinien und StandardsGuidlines & Standards
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Richtlinie 93/42/EWG | Council Directive 93/42/EEC |
Revision of MDD 93/42/EEC | |
IVD Richtlinie 98/79/EG | IVD Directive 98/79/EC |
IEC 60601-1:2005:3. Ausgabe | IEC 60601-1:2005:3rd Edition |
NEW! | |
Design Dossiers | |
Extension of EC Certificates | |
Gebrauchstauglichkeit von Medizinprodukten | Usability of Medical Devices |
Übergang zur EU-Richtlinien 2007/47/EG | Transition to EC Directive 2007/47/EC |
Clinical Department
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Clinical Data Requirements for EC Certificate Extension | |
Clinical Data Requirements in the Era of Directive 2007/47/EC | |
Material tierischen Ursprungs | Material of Animal Origin |
Assessment of Medical Devices Incorporating Material of Animal Origin | |
Human blood derivatives | |
MD utilizing material of Animal Origin | |
Biological safety | |
Biological evaluation | |
Tools for tissue engineering | |
Advanced Therapy Medicinal Products | |
Internationale VermarktungInternational Affairs
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Globalisierung Medizinproduktezulassung | Globalization of Medical Device Approval |
FDA 510(k) | |
Marktzugang USA und Kanada | Access USA and Canada |
Japanese PAL | |
PAL - MHLW Movement | |
PAL - Transitional Measures for Approved Medical Devices | |
PAL - Change application and notification | |
PAL - Maintain approvals/certificates | |
PAL - Fundamental Info | |
Marktzugang Russische Föderation (GOST) | Access Russian Federation (GOST) |
Access Australia | |
Chinese Approval | |
Weitere DienstleistungenFurther services
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Qualitätsmanagement in der Dialyse | Quality Management in Dialysis |
Therapeutische Ultraschallgeräte EN 60601-2-5 | Therapeutic ultrasound devices EN 60601-2-5 |
Diagnostische Ultraschallgeräte EN 60601-2-37 | Diagnostic ultrasound devices EN 60601-2-37 |
Medical device software Download [ PDF 74 kB ] | |