Home
Quality Management System
Resource Management
Product Realization
Measurement Analysis Improvement
Welcome to the ISO 13485:2016 Standard knowledge center
Quality Management System
»
ISO 13485 Software – What do I need to know?
October 23, 2022,
No Comments
on ISO 13485 Software – What do I need to know?
Practical FAQ about ISO 13485
September 26, 2022,
No Comments
on Practical FAQ about ISO 13485
FDA QSR 21CFR 820 Transition to ISO 13485:2016 – FAQ
September 20, 2019,
No Comments
on FDA QSR 21CFR 820 Transition to ISO 13485:2016 – FAQ
Software Validation ISO 13485 – Validation of Software applications
June 11, 2018,
No Comments
on Software Validation ISO 13485 – Validation of Software applications
Product Realization
»
7.3.7 Design and development validation – Objectives
September 15, 2018,
No Comments
on 7.3.7 Design and development validation – Objectives
Challenges manufacturers of medical devices are facing when implementing labels under the ISO 13485
August 12, 2018,
No Comments
on Challenges manufacturers of medical devices are facing when implementing labels under the ISO 13485
The challenges of Computer Systems Validation (CSV)
July 31, 2018,
No Comments
on The challenges of Computer Systems Validation (CSV)
ISO 13485:2016 Standard – 7.5.8 Identification
June 12, 2018,
No Comments
on ISO 13485:2016 Standard – 7.5.8 Identification
Resource Management
»
ISO 13485:2016 Standard – Maintaining documented procedure for Human resources
September 15, 2018,
No Comments
on ISO 13485:2016 Standard – Maintaining documented procedure for Human resources
ISO 13485:2016 Standard – 6.4.2 Contamination control
June 12, 2018,
No Comments
on ISO 13485:2016 Standard – 6.4.2 Contamination control
ISO 13485:2016 Standard – 6.3 Infrastructure
June 11, 2018,
No Comments
on ISO 13485:2016 Standard – 6.3 Infrastructure
Measurement, analysis and improvement
»
ISO 13485 Standard:2016 – 8.3.4 Rework
September 15, 2018,
No Comments
on ISO 13485 Standard:2016 – 8.3.4 Rework
ISO 13485 Standard:2016 – 8.5.2 Corrective Action
June 12, 2018,
No Comments
on ISO 13485 Standard:2016 – 8.5.2 Corrective Action
ISO 13485:2016 Standard – 8.2.1 Feedback
June 12, 2018,
No Comments
on ISO 13485:2016 Standard – 8.2.1 Feedback
Ads
Categories
FDA
ISO 13485: Risk Management
ISO 13485:2016 Section 5 – Management responsibility
ISO 13485:2016 Standard for Quality management systems — Requirements for regulatory purposes
ISO 13485:2016 Standard Section 4 – Quality management system
ISO 13485:2016 Standard Section 6 – Resource management
ISO 13485:2016 Standard Section 7 – Product realization
ISO 13485:2016 Standard Section 8 – Measurement, analysis and improvement
Our Tags
4.1.6
4.2.4
4.2.5
Audit trail
Clinical Evaluation
Control of documents
Control of records
design and development
DHR
Documents control
FDA
ISO 13485 Software
life-cycle
Literature
Quality management system
Quality objectives
Regulatory requirements
Risk Analysis
Risk Management
software
validation
Validation of Software
Sitemap
