This clinical evaluation & ISO 14971 training will discuss how the new changes in MDD and the risk management requirements per 14971 overlap and how manufacturers can establish one integrated system to meet both the requirements.
Areas Covered in the Seminar:
- The Overview.
- Clinical Evaluation
- Risk Management
- Their touch points
- The Documents and the Sources
- EU Directives
- Harmonized Standards
- EU Guidance Documents
- NBOG Guidance Documents
- GHTF Guidance Documents
- Changes to the MDD.
- Requirements for Clinical Evaluation
- Clinical Evaluation changes in Annex I
- Clinical Evaluation changes in Annex X
- Clinical Evaluation using MEDDEV 2.7/1.
- Stage 1 Identify the pertinent standards and clinical data
- Stage 2 Appraise each individual data set
- Stage 3 Analyze each individual data set
- Clinical follow-up using GHTF/SG5/N4:2010.
- Risk Management.
- Status of ISO 14971
- Clinical Evaluation and Residual Risk
- Joint follow-up for Clinical Evaluation and Risk Management
Related Technical Documents:
- Medical Device Directive (MDD)
- EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
- MEDDEV 2.7/1 rev.3 Clinical evaluation: Guide for manufacturers and notified bodies
- MEDDEV 2.7/2 Guide for Competent Authorities in making an assessment of clinical investigation; notification
- GHTF SG5/N1R8:2007 Clinical Evidence – Key Definitions and Concepts
- GHTF SG5/N2R8:2007 Clinical Evaluation
- GHTF/SG5/N4:2010 Post-Market Clinical Follow-Up Studies
- NBOG CL 2010-1 Checklist for Audit of Notified Body's Review of Clinical Data/Clinical Evaluation
Who Will Benefit:
This webinar provides information for people involved in risk management and clinical evaluation of medical devices.
- Quality Managers
- Regulatory Affairs Managers
- Risk Managers
- Management Representatives
- Design Engineers
- Notified Body Contacts
For More Information: