contact@lne-america.com 1-301-495-0477 lne-america.com LNE/G-MED North America, Inc Embedded Software in Medical Device : Common Regulatory and Quality Misconceptions. 9/28/2016 Do not distribute or reproduce without permission 1
contact@lne-america.com 1-301-495-0477 lne-america.com Speaker Mohamed Alsaadi Certification Project Manager Lead Auditor LNE / G-MED North America, Inc. 9/28/2016 Do not distribute or reproduce without permission 2
contact@lne-america.com 1-301-495-0477 lne-america.com What is an embedded medical device software? 9/28/2016 Do not distribute or reproduce without permission 3
contact@lne-america.com 1-301-495-0477 lne-america.com One of the areas of important development in medical devices has been the role of software, as an integral component of a medical devices. 9/28/2016 Do not distribute or reproduce without permission 4
contact@lne-america.com 1-301-495-0477 lne-america.com Definitions Software : is defined as a set of instructions that processes input data and creates output data. IMDRF/SaMD WG/N10FINAL:2013 Stand alone software : means software which is not incorporated in a medical device at the time of its placing on the market or its making available. MEDDEV 2.1/6 July 2016 Medical device software SOFTWARE SYSTEM that has been developed for the purpose of being incorporated into the MEDICAL DEVICE being developed or that is intended for use as a MEDICAL DEVICE in its own right. IEC 62304:2006 9/28/2016 Do not distribute or reproduce without permission 5
contact@lne-america.com 1-301-495-0477 lne-america.com Delivering healthy embedded SW The use of embedded software in medical devices is increasing rapidly. Any company active in this market must ensure the highest quality of software development. By adopting and enforcing a demonstrable commitment to software quality, medical device developers are better positioned to meet regulatory requirements when developing embedded software. 9/28/2016 Do not distribute or reproduce without permission 6
contact@lne-america.com 1-301-495-0477 lne-america.com What is MD software in general • software may be constructed either by coding (i.e., programming) or by assembling together previously coded software components (e.g., from code libraries, off-the-shelf software, etc.) forming an integral part of medical device technology. • Whether the medical device will be used in the home or in a hospital environment, system failures are not an option. Making the right software development platform choice can help avoid problems and get the device to market on time and within budget. Source: CDRH/ General Principles of Software Validation; Final Guidance for Industry and FDA Staff 9/28/2016 Do not distribute or reproduce without permission 7
contact@lne-america.com 1-301-495-0477 lne-america.com The software is often part of the Medical Device Technology, Determining the safety and effectiveness of the MD containing software, based on software intended use. The software must demonstrate that its use meets the objectives without unacceptable risks. 9/28/2016 Do not distribute or reproduce without permission 8
contact@lne-america.com 1-301-495-0477 lne-america.com Why and how does a software differ from hardware? • A number of errors related to software are introduced during the design phase. • Software can be much more complex than hardware. • It is difficult to fully test the software and test all possible scenarios. • Software includes often passive hidden defects. • Software is more easily modified than the hardware. Source: GPSV 9/28/2016 Do not distribute or reproduce without permission 9
contact@lne-america.com 1-301-495-0477 lne-america.com Medical Applications in which Embedded Software has been deployed • Blood Gas Analyzer & Monitors • Cardio Machines • Defibrillator • Dialysis Machine • Digital Thermometers • Elecrtrocardiogram Devices • Infusion & Insulin Pumps • Glucose Meters & Portable Meters and Oximeters 9/28/2016 Do not distribute or reproduce without permission 10
contact@lne-america.com 1-301-495-0477 lne-america.com Requirements introduced by directive 93/42/EEC and directive 90/385/EEC) It is necessary to clarify that software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device, is a medical device. Software for general purposes when used in a healthcare setting is not a medical device. 9/28/2016 Do not distribute or reproduce without permission 11
contact@lne-america.com 1-301-495-0477 lne-america.com The European regulatory context The essential requirement of Directives 93/42/EEC & 90/385/EEC (Annex 1 Article 12 Directive 93/42/EEC and Annex 1 Article 9 Directive 90/385/EEC): For devices which incorporate software or which are themselves medical software, the software must be validated on the basis of the state of the art, taking into account the principles of the development cycle as well as risk management, validation and verification. 9/28/2016 Do not distribute or reproduce without permission 12
contact@lne-america.com 1-301-495-0477 lne-america.com How to meet the essential requirements? Harmonized standards They are considered as voluntary standards in the field of new approaches directives. However, they give a “presumption of conformity with essential requirements”. Notified bodies and competent authorities consider a harmonized standard as a preferred means to measure / determine the methods deployed by the manufacturer. 9/28/2016 Do not distribute or reproduce without permission 13
contact@lne-america.com 1-301-495-0477 lne-america.com Improving Code Quality While Complying with EN 62304 Marketing medical devices in Europe require demonstrating conformity to Essential Requirements and several Harmonized standards can be used to do so. EN 62304 is one of these standards. The standard provides a list of tasks and activities that support the safe design and maintenance of medical device software. The goal of this is to ensure the software does what is intended without causing any unacceptable risks. Therefore, EN 62304 relies heavily on Risk Management strategies. 9/28/2016 Do not distribute or reproduce without permission 14
contact@lne-america.com 1-301-495-0477 lne-america.com When to apply EN 62304 • This standard applies to the development and maintenance of medical device SW when software is itself a medical device or when software is an embedded or integral part of the final medical device. • This standard should be used in conjunction with other relevant standards for the development of medical device: – ISO 13485 and ISO 14971 provides a management environment that establishes a basis for a company to develop products. – Safety standards such as IEC 60601-1 give specific instructions for creating safe MD. – For embedded MD Software, EN 62304 provides more detailed instructions on development and maintenance processes. 9/28/2016 Do not distribute or reproduce without permission 15
contact@lne-america.com 1-301-495-0477 lne-america.com EN 62304 Scope It identifies the requirements for each life cycle process. There are five main processes: • Software Development • Software Maintenance • Software Risk Management • Software Configuration Management • Software problem resolution 9/28/2016 Do not distribute or reproduce without permission 16
contact@lne-america.com 1-301-495-0477 lne-america.com EN 62304 scope and classification It introduces a notion of software risk classification based on the hazards to which the software system can contribute to the patient, operator or other persons: • Class A : No injuries or damage to health is possible • Class B : Non-serious injury is possible • Class C : Death or serious injury is possible 9/28/2016 Do not distribute or reproduce without permission 17
contact@lne-america.com 1-301-495-0477 lne-america.com How to document the class of the software? • Manufacturer must record the safety class of the software assigned to each software system into the risk management file. • When a software system is decomposed into SOFTWARE ITEMS, and when a SOFTWARE ITEM is decomposed into further SOFTWARE ITEMS, such SOFTWARE ITEMS shall inherit the software safety classification of the original SOFTWARE ITEM (or SOFTWARE SYSTEM) unless the MANUFACTURER documents a rationale for classification into a different software safety class. Such a rationale shall explain how the new SOFTWARE ITEMS are segregated so that they may be classified separately. • For each SOFTWARE SYSTEM, until a software safety class is assigned, Class C requirements shall apply. 9/28/2016 Do not distribute or reproduce without permission 18
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