| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 25.03.2014 11:00:47 |
| Modified: | 00:00:00 |
| Advanced : | |
| Appears In: | Do CE product approval, 7.2.1 Ermittlung der Anforderungen bezüglich des Produkts, 7.3.3 Entwicklungseingaben, 7.2.1 Determination of requirements related to the product, 7.3.2 Design and development inputs, 3.2 Absatz 3 (c) |
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EA Project Browser
Overview- Organisation Chart
- Staff
- Roles
- Projects
- SOPs
Process landscape
Management- Quality and Regulatory
Quality and Regulatory- QA_Quality Assurance
- QM_Quality Management
- RA_Regulatory Affairs
- RA_Regulatory Affairs
«BusinessProcess» Define UDI and SN/LOT number- «BusinessProcess» Develop approval strategies
- «BusinessProcess» Do CE product approval
- Do CE product approval
«Activity» Apply for product certification- «Activity» Check and declare compliance with ER 93/42/EEC
- «Activity» Check and declare compliance with ER 98/37/EEC (if applicable)
- «Activity» Compile ETF
- «Activity» Create declaration of conformity
- «Activity» ETF assessment
- «Activity» Initial CE approval audit
- «Activity» Select representative product sample for audit
«EndEvent» Medical device CE approved
«StartEvent» Need for CE approval
- «BusinessProcess» Do FDA approval
- «BusinessProcess» Do language localisation
- «BusinessProcess» Do medical device reporting
- «BusinessProcess» Register MD in EU
- «BusinessProcess» Register company in EU
- «BusinessProcess» Track applied norms and standards
- RM_Risk Management
- «BusinessProcess» Plan resources and budget Q&R
- «BusinessProcess» Report Q&R
- Clinical Marketing
- Research and Development
- Operations
- Customer Support
- Sales
- Finance
- Information Technology
- Human Resources
- Templates
- Software tools
- Equipment
- Facilities
- Products
- Compliance
- Sandbox