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Our servicesBased on our broad experience in medical device regulatory affairs and consistent with current usability rules and regulations, we offer: • Assistance with contextual and requirements analysis• Assessment of user interface and device designs
according to ergonomic criteria and subsequent defi nition of usability specifi cation requirements
• Planning, implementation and evaluation of usability tests based on your needs and requirements
• Review of your usability documents• In-house seminars on ergonomics and usability
We have been certifi ed to carry out preclinical and clinical contract research in the fi eld of medical technolo gies according to ISO 9001:2008.
Your benefi tWe focus on providing customized, comprehensive solutions for our clients, offering fast and professional support in the complex fi eld of medical device usability.
We will gladly integrate existing cooperation between your company and clinicians into your collaboration with novineon CRO.
As our client, you are involved in the process from the beginning and receive continuous updates about all relevant aspects.
Who we arenovineon CRO & Consulting Ltd is a consulting and research company in the fi eld of health care technology.
As a professional service provider situated at the inter-face between scientifi c research and business and indus-try, we are operating worldwide. Our CRO (Contract Research Organization) division supports manufacturers of medical devices in all aspects of preclinical and clinical research as well as regarding product authorization.
We work with an international network of leading med-ical facilities and institutions, and our clients include international healthcare companies as well as small- and medium-sized enterprises and start-up ventures.
Contact usnovineon CRO & Consulting Ltd
Dorfackerstrasse 2672074 Tuebingen
Phone: +49 7071 / 989 79-120Fax: +49 7071 / 989 79-220
www.novineon.com
Dr. rer. nat. Marion Fehlker
E-mail: [email protected]: +49 7071 / 989 79-124
Dr. rer. nat. Timo Weiland
E-mail: [email protected]: +49 7071 / 989 79-123
For further information on Post-Market Surveillance, PMCF and clinical evaluations, please visit: www.clinicalevaluation.com
Usability of medical devices
according to IEC 62366and IEC 60601-1-6
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Specifi cation of usabilityThe results of process and risk analysis are the basis for specifying user-requirements for the device design. These specifi cations are fundamental for subsequently evaluating usability.
Verifi cation of usabilityIn this step of the usability process, conformity of the ergonomic characteristics with previously defi ned specifi cations is examined. Possible ways of verifi cation include expert interviews, focus groups and user tests. In case of non-conformity with specifi cations, solutions for improvement are developed.
Validation of usabilityAccording to a pre-defi ned validation plan, usability is now validated. Options for this validation include user application tests or usability tests. A dedicated valida-tion report documents conformity with the results of the process analysis and with defi ned specifi cations as well as defi ciencies and problems with regard to usability.
Usability fi leThe entire usability process has to be documented in a usability fi le.
Requirements
Ergonomics and usabilityAccording to the essential requirements outlined in the Medical Device Directive (MDD) 93/42/EWG, medical devices have to be designed and manufactured in a way that eliminates or reduces risks associated with ergonomic criteria.
High usability is the objective of an ergonomic design based on the needs of common users. It includes effectiveness, effi ciency, ease of learning/training and overall user satisfaction.
Objective of usability processStandards IEC 60601-1-6 and IEC 62366 specify a usabil-ity design process aiming at preventing user errors which could compromise product safety. These standards also facilitate the design of more user-friendly devices and thus help increase customer satisfaction.
Relevant regulations• European Medical Device Directive, MDD 93/42/EEC• Council Directive relating to active implantable medical
devices, 90/385/EEC• EC Directive On In Vitro Diagnostic Medical Devices,
98/79/EC• National Medical Device Regulations, e.g. German
Medical Devices Act, MPG• National and international regulations on medical
device operators• National and international product liability law, e.g.
German ProdHaftG• National and international product safety regulations,
e.g. German ProdSG
Relevant standardsManufacturers of medical devices are required to ana-lyze, specify, design, verify and validate usability as part of the safety of medical devices. International standards IEC 60601-1-6 and IEC 62366 defi ne requirements and guidance for this usability process:• IEC 60601-1-6 (Medical electrical equipment – Part
1-6: General requirements for basic safety and essential performance – Collateral standard: Usability)
• IEC 62366 (Medical devices – Application of usability engineering to medical devices)
Usability processThe usability process identifi es, evaluates and reduces potential usability-related risks associated with intended use as well as with usage errors.
The usability process includes process analysis and risk analysis as well as specifi cation, verifi cation and valida-tion of usability.
Process analysisThe basis for all further parts of the usability process is a thorough process analysis. This analysis concerns the in-tended purpose of use of the medical device, user and task profi les, and the context of use or operating functions.
Risk analysisIn order to identify potential user-related risks and to evaluate those risks, a dedicated risk analysis, carried out according to ISO 14971, is part of the usability process.
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Contact RequestPlease contact me regarding usability services:
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