“Perspectives On EN ISO 14971:2012 & EN ISO 13485:2012”

The presentation discusses the following aspects of:

• EN ISO 14971:2012

• The content deviations have been introduced in the EN standard for the first time, and clarity is yet to be forthcoming from Notified Bodies.

• The presentation will discuss the consensus arrived at in a discussion between:
  - Members of the committee ISO/TC 210/JWG 1 responsible for the development of ISO 14971:2007
  - Convener of the Medical Device Working Group for ISO 13485 at International Accreditation Forum
  - Other members of the medical device community that included the speaker

• The work of the speaker has been used by COCIR ( European Coordination Committee of the Radiological, Electro-medical and Healthcare IT Industry) in its submissions to Group of Notified Bodies for arriving at a consensus interpretation to the
  Content Deviations introduction to the current EN ISO 14971:2012 standard.

• EN ISO 13485:2012

• Certain anomalies have crept into the foreword to the standard, when read in the context of establishing conformity with the Essential Requirement of MDD and the associated routes for assessing conformity.

• There are certain issues that have crept into industry practice for implementing and assessing conformity to ISO 13485:2003 and its European Standard.

• The issues are experienced globally.

“Risk Management: A Tool For Certification Or A Smart Decision”

The globalization of the medical device marketplace, combined with the growth of medical device usage, has led to a significant increase the complex task of making a medical device safe for human use activity among device manufacturers. Dear all, we know that Medical Device (MD) and IVD products in market are required to be safe. What is this safety? Regulation, manufacturer and user interpret this differently but still come down to a common acceptance of “reasonable risks”, which of course depends on the magnitude of the benefit. The stake holders try to maintain this benefit-risk balance by making sure that products are developed, tested, manufactured, labeled, prescribed, dispensed, and used in a way that maximizes benefit and minimizes risk.

A quick revision of ISO 14971:2009 to ISO 14971:2012, regulatory agencies examining risks in terms of the worst possible outcome, and ever increase in warning letters citing risk management deficiencies highlights the importance of risk management, its linkage with QMS processes more than ever before. And with this, the roles of stake holders have evolved substantially over the period with dramatic increase in scrutiny of the product risk management practices.

Reduction in risks of failure of risk management is not possible through a strictest regulation alone but through a proactive vision which looks at risk management beyond a “file for audit” to “basis for decisions” throughout product’s life cycle. Inadequacy in understanding and implementation fuels the misguided notion that “risk management practices” adds little value to design production and post production stages. On the other hand a well executed risk management serves as a powerful tool for innovation and growth.

The companies need to develop risk management processes through cross functional involvement and integration with other QMS processes, and robust governance by management towards maximizing results and minimizing risk. Most risk management processes fail in demonstration of levels of risks & acceptability criteria and identification of hazards as well as confusion between hazard and risks. The risk assessment is arbitrary and risk control measures non-specific. Thus, the need of the hour is to unlearn and relearn the concept and process of risk management. Interesting examples shall be discussed further.