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Posts
- ISO 13485 Software – What do I need to know?
- Practical FAQ about ISO 13485
- Comparison Matrix FDA QSR 21CFR 820/ISO 13485:2016
- FDA QSR 21CFR 820 Transition to ISO 13485:2016 – FAQ
- ISO 13485 Standard:2016 – 8.3.4 Rework
- ISO 13485:2016 Standard – Maintaining documented procedure for Human resources
- 7.3.7 Design and development validation – Objectives
- ISO 13485 – 5.4.1 – Quality objectives
- Clinical Evaluation and Risk management – Interesting Inputs for the Design Phase
- ISO 13485 and Risk Management – Critical Relations of the new kind
- ISO 13485: Risk Management integrated in the Design and the Development
- Challenges manufacturers of medical devices are facing when implementing labels under the ISO 13485
- The challenges of Computer Systems Validation (CSV)
- ISO 13485:2016 Standard- Table of contents
- Why choose the book ISO 13485:2016 – A Complete Guide to Quality Management in the Medical Device Industry
- Introducing the project ISO 13485:2016 – A Complete Guide to Quality Management in the Medical Device Industry
- ISO 13485 Standard:2016 – 8.5.2 Corrective Action
- ISO 13485:2016 Standard – 8.2.1 Feedback
- ISO 13485:2016 Standard – 7.5.8 Identification
- ISO 13485:2016 Standard – 7.5.6 Validation of processes for production and service provision
- ISO 13485:2016 Standard – 7.5.1 Control of production and service provision
- ISO 13485:2016 Standard – 7.1 – Planning and documenting risk management activities
- ISO 13485:2016 Standard – 6.4.2 Contamination control
- Software Validation ISO 13485 – Validation of Software applications
- ISO 13485:2016 Standard – 6.3 Infrastructure
- ISO 13485 Standard:2016 – 4.2.5 Control of records
- ISO 13485 Standard:2016 – 4.2.4 Control of documents