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.
Why Should You Attend:
The changes to the Medical Device Directive (MDD) should be in place by now. However, many manufacturers didn't recognize the March 21, 2010 was the final date for compliance, rather than the start of the transition period. One of the new requirements has the device manufacturer update the clinical evaluation (and its documentation) with data obtained from the post-market surveillance.
Also Risk Management, following ISO 14971, requires a Risk Management Plan that includes activities related to collection and review of relevant production and post-production information.
This webinar will include a discussion of clinical evaluation, including the recommendations from MEDDEV 2.7.1 (Rev. 3) Clinical Evaluation: A Guide for Manufacturers and Notified Bodies. We will also cover MEDDEV 2.12-2 Guidelines on Post Market Clinical Follow-Up.
We look at some approaches to write a post-production collection and review plan. As Medical Device Directive (MDD) and ISO 14971 requirements overlap, so the manufacturer can establish one integrated system to meet both sets of requirements. This webinar explains each system, and show how they are related. The webinar uses guidance documents from the EU and the GHTF to help explain the systems and clarify the regulatory expectations.
Areas Covered in the Seminar:
- The Overview.
- Clinical Evaluation
- Risk Management
- Their touch points
- The Documents and the Sources
- 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.
- Scope
- Stage 1 Identify the pertinent standards and clinical data
- Stage 2 Appraise each individual data set
- Stage 3 Analyze each individual data set
- Report
- Clinical follow-up using GHTF/SG5/N4:2010.
- Objectives
- Design
- Study
- Implement
- 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
Instructor Profile:
Daniel O'Leary, is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.
