On July 13, 2016, the French national Agency for Medicines and
Health Products Safety published a study on the safety of medical devices
software. The study's objectives are to assess the European
normative framework for software development and safety and produce
recommendations for manufacturers.
In order to correctly implement the current standards, the study
recommends that manufacturers focus on data related to principles
(e.g., sustainability and confidentiality) identified in the
software database, specification and design verification, impact
analysis of software changes, and a thorough risk analysis. The
study also proposes to clarify or create new requirements to
existing NF EN 62304, EN 62366, and ISO 14971 standards and
provides various recommendations intended to cover most of the
software types to fill gaps identified in applicable norms
regarding process, development techniques, and safety and security
categories. The proposed reform aims to address new risks in a
context of health care technological revolution and to ensure the
safety of medical devices software.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
