ISO 14971 – Clause By Clause

This training is for regulatory and quality professionals, regardless of their background, seeking a clause by clause understanding of ISO 14971.

The training covers the following parts and clauses of ISO 14971:

• Foreword
• Introduction
• Clause 1 – Scope
• Clause 2 – Normative references
• Clause 3 – Terms and definitions
• Clause 4 – General requirements for risk management system
• Clause 5 – Risk analysis
• Clause 6 – Risk evaluation
• Clause 7 – Risk control
• Clause 8 – Evaluation of overall residual risk
• Clause 9 – Risk management review
• Clause 10 – Production and post-production activities
• Annexes A-C

It will, in particular:

• address the meaning and implications of ‘as far as possible without adversely affecting the benefit-risk ratio’ for the purposes of Regulation (EU)  017/745 (MDR) and Regulation (EU) 2017/746 (IVDR);
• provide real-world, practical examples of approaches to records and documentation – both the good and the bad; and
• facilitate sharing and discussion of the interpretations and practical implementation of the requirements of ISO 14971, specifically as they relate to ISO/TR 24971.

If the training is delivered on-site, there will be individual and group activities focussed on examining and discussing particular risk control measures – or the lack thereof. You will also get to inspect and test perhaps one of the most hazardous pieces of medical electrical equipment of recent times.

In addition to having fun and gaining new theoretical (and practical) knowledge, you will receive training materials which you can take away for future reference.