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Verordnungen (EU) 2017/745
TechFile Factory
OEM/PLM Konstellation
In-vitro-Diagnostika – Verordnung (EU) 2017/746
Clinical Affairs
Klinische Bewertung
Klinische Studien
Post-Market Surveillance/Post-Market Clinical Follow-up
Kurzbericht über Sicherheit und klinische Leistung (SSCP)
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Anforderungen der FDA (USA)
Internationale Anforderungen an Medizinprodukte
CFDA/NMPA (China) – Anforderungen
Risikomanagement
ISO 14971 für Medizinprodukte
Risikomanagement nach IEC 80001-1
Besondere Anforderungen an das Medizinprodukt
Softwareentwicklung
Entwicklung nach IEC 62304/IEC 82304
Medical Apps / Health Software
Usability
IEC 62366 - Anforderungen an die Gebrauchstauglichkeit von Medizinprodukten
Usability - Risikomanagement - Klinische Bewertung - Post-Market Surveillance
Qualitätsmanagement
ISO 13485
Regulatorische/Normative Bewertung
Implementierung eines vollständigen Qualitätsmanagementsystems
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Neue Anforderungen an Ihre Medizinprodukte und Prozesse
Datenschutzgrundverordnung
Gutachten
Biologische Beurteilung von Medizinprodukten
Biologische Beurteilungsstrategie
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Online – Seminare
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eLearning
EU MDR & EU IVDR
European Union Medical Device Regulation – EU MDR
European Union In Vitro Diagnostic Device Regulation – EU IVDR
Post Market Surveillance and Vigilance Requirements for Manufacturers (EU 2017/745)
US FDA Regulations
US Medical Device Regulations – A Comprehensive Overview
US FDA Medical Device Reporting Requirements
US FDA Pre-submission (Q-Sub) Program – Requesting FDA Feedback
US FDA Medical Device Complaint Handling and Servicing – Plus ISO 13485:2016 Requirements
US Quality Systems & Combination Products – Practical Application
510K Changes Guidance – Deciding When to Submit a new 510(k) for Existing Devices
Data Integrity: Overview and Documentation Completion, Review and Approval
International Standards and Programs
ISO 13485:2016 – International Medical Device Quality Management System (QMS) Standard
ISO 14971:2019 – Application of Risk Management to Medical Devices
MDSAP
MDSAP and Regulatory Transitions – The Basics Virtual Training
Medical Device Country-Specific Regulatory Requirements (5 course bundle – MDSAP participating counties)
Country-Specific Medical Device Regulations
Australia Medical Device Regulations – A Comprehensive Overview
Brazil Medical Device Regulations – A Comprehensive Overview
Canada Medical Device Regulations – A Comprehensive Overview
Japan Medical Device Regulations – A Comprehensive Overview
United States Medical Device Regulations – A Comprehensive Overview
China Medical Device Regulations – A Comprehensive Overview
Global Quality Systems Requirements
US Quality Systems & Combination Products – Practical Application
Design Controls for Medical Devices and IVDs
US FDA Medical Device Complaint Handling and Servicing – Plus ISO 13485:2016 Requirements
Data Integrity: Overview and Documentation Completion, Review and Approval
Online Beratung
Kommende Veranstaltungen
18
Apr
MDR MEETS HYGIENE - Kooperation zwischen NSF PROSYSTEM und Dr. Brill+ Partner (DE)
18 Apr 24
Hamburg
23
Apr
USABILITY (DE)
23 Apr 24
Hamburg
25
Apr
HEALTH SOFTWARE (DE)
25 Apr 24
Hamburg