Online Consulting
✆
+49 40 668 788-100
Hamburg, Germany
Home
Services
EU Regulations
TechFile Factory at NSF International
OEM/PLM Constellations
In Vitro Diagnostic – Regulation (EU) 2017/746
Clinical Affairs
Clinical Evaluation
Biological Safety
Clinical Investigation
Post-Market Surveillance/ Post-Market Clinical Follow-up
Regulatory Affairs
Technical Documentation
FDA Requirements (USA)
International Requirements for Medical Devices
CFDA/NMPA (China) – Requirements
Risk management
ISO 14971
IEC 80001-1
Special requirements for medical devices
Software development
Development according to IEC 62304/IEC 82304
Medical Apps / Health Software
Usability
IEC 62366
Usability – Risk Management – Clinical Evaluation
Quality Management
ISO 13485
Regulatory/Normative Assessment
Implementation of a Complete Quality Management System
Audits and Inspections
Internal Audits
Supplier Audit
Audits by Authorities or Notified Bodies
Expert Opinions
In Vitro Diagnostic Services
Performance Evaluation & Performance Studies
Risk Management & Post-Market Surveillance (PMS)
TechFile Factory & Quality Management Services
Regulatory Affairs
Standards and Trends
New requirements for your processes and medical devices
Interim and Crisis Management
General Data Protection Regulation
PROSYSTEM Academy
About PROSYSTEM Academy
eLearning
Trainings
International Events
Keynotes
News
Company
About NSF PROSYSTEM GmbH
Partners
Imprint
Contact
Careers
Downloads
Register
Please use the following form to register at PROSYSTEM AG.
Username
*
E-Mail
*
First Name
*
Last Name
*
Company
*
Phone
*
I want PROSYSTEM to keep me informed about recent regulatory developments and events hosted by PROSYSTEM, including new seminars and expert conferences via email.
Yes
No
*
marks required fields
Online Beratung
Upcoming Events
Currently no events are planned