Proposed Medical Design Requires The Certification And...

As part of Class I sterile, the proposed medical design requires the certification and approval by a Notified Body (NB) for manufacturing and sterility standards [14]. At the same time the Council Directive 93/42/EEC recommends to conform to the EN ISO 13485 and EN ISO 14971 European standards, although it is not require [14][26][27]. Furthermore, for basic class I devices, only the declaration of conformity is required before receiving the CE marking, making market entrance more accessible for small companies [13]. iii. Standards Standards are published documents by several international and national organisations that establish the basic specifications and procedures that manufactures and product have to meet to ensure the safety and†¦show more content†¦These include different requirements such as the heat treatment, the material hardness (40HRC to 48 HRC) or the steel grade (ISO 7153-1) of the surgical device [29]. Engineers should asses what standards are relevant for their device and how these affect the design specification. iv. FMEA Failure Modes and Effects Analysis (FMEA) is a proactive technique that allows the identification and prevention of errors before they occur [17]. This is especially relevant in the medical sector, where human life is constantly at risk. The FMEA aims to prevent failure by prioritizing which of the companies’ tasks needs greater control and improvement. This is done by using a weighting system that accounts for occurrence and the severity of the hazard [18]. For medical devices the main regulatory framework for risk management can be found in ISO 14971 [27]. This voluntary standard for medical devices, focuses on how companies can make safer devices by preventing and mitigating the possible risk factors involve during the life-cycle of the product. Other important factor of the FMEA is the development of an optimal testing methodology to ensure that the product is suitable for its application [17]. Some of the these test are standardize by notified bodies, such as the test fo r wear in knee prosthesis (ISO 14243) or the standard guide for evaluating modular hip and knee joint components (ASTM F1814-15)Show MoreRelatedUnderstanding Eu Mdr And Ivdr. European Union Is One Of1133 Words   |  5 Pagesmarkets for Medical Device. Current European Union legislation for regulating medical device was harmonized in 1990s. Basic aim of these legislations was to promote high level of protection for human health, also good functioning of market-Thus ensuring safety and performance of medical devices (Regulatory Framework, 2017). 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