| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Created: | 31.03.2014 |
| Modified: | 07.10.2017 11:57:10 |
| Diagram Elements : |
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EA Project Browser
Overview- Organisation Chart
- Staff
- Roles
- Projects
- SOPs
- Templates
- Software tools
- Equipment
- Facilities
- Products
- Compliance
Compliance
ISO 13485:2016-08 Qualitätsmanagement- ISO 13485:2012-11 Quality management
- ISO 14971 Risk management
- IEC 62304 Software life-cycle processes
- IEC 62366 Usability
- CFR 820 Code of Federal Regulations Title 21
- CFR 820 Requirements
- Subpart B - Quality System Requirements
- Subpart C - Design Controls
- Subpart D - Document Controls
- Subpart E - Purchasing Controls
- Subpart F - Identification and Traceability
- Subpart G - Production and Process Controls
- Subpart H - Acceptance Activities
- Subpart I - Nonconforming Product
- Subpart J - Corrective and Preventive Action
- Subpart K - Labeling and Packaging Control
- Subpart L - Handling, Storage, Distribution, and Installation
- Subpart M - Records
- Subpart M - Records
- CFR 820.180 General requirements
- CFR 820.181 Device master record
- CFR 820.184 Device history record
- CFR 820.186 Quality system record
- CFR 820.198 Complaint files
CFR 820.198 Complaint files
«Functional» CFR 820.196 (a) Receiving, reviewing and evaluating of complaints- «Functional» CFR 820.196 (b) Handle with non investigated complaints
- «Functional» CFR 820.196 (c) Complaints involving possible failures of a device
- «Functional» CFR 820.196 (d) Complaints that have to reported to FDA
- «Functional» CFR 820.196 (e) Record investigation
- «Functional» CFR 820.196 (f) Formally designated complaint unit oustide the company
- «Functional» CFR 820.196 (g) Formally designated complaint unit outside USA
- Subpart N - Servicing
- Subpart O - Statistical Techniques
- Council directive 93/42/EEC, Annex II
- ISO 27001 Information technology - Security techniques
- IEC 60601-1 Processes
- Sandbox