Industrial Equipment News

DEC 2016

IEN (Industrial Equipment News) is the leading resource for industrial professionals, providing product technology, trends and solutions impacting the industrial market. IEN reaches manufacturers, designers, distributors & supply chain professionals.

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34 IEN / DECEMBER '16 www.ien.com Today's Designer In addition to flexible performance specifications, commer- cial components also have a great deal of design flexibility. Most components evolve incrementally, in a series of slight adjustments made to the base design to enhance one or more features and achieve lower cost, improved functional- ity, or enhanced performance. Manufacturers of commercial components are free to communicate the details of such revisions to their customers in any of several ways (data sheets, etc.), or not at all. For instance, a commercial com- ponent manufacturer could change the composition of the raw materials without ever notifying customers, provided that the change met the manufacturer's internal qualification procedures, didn't alter the component's physical size or shape, and didn't affect the component's ability to perform within the electrical parameters listed in its product catalog. Given these limitations, one could easily assume that re- vised commercial components would deliver essentially the same performance as the originals, and that's more or less true with regard to their performance in consumer designs, which both allow and account for components with wider parametric ranges. However, if components revised accord- ing to these limitations are employed in applications with the exact same operating conditions, but even slightly different electrical performance, critical complications can arise. As such, the manufacturing of medical devices is a tight- ly regulated industry, with necessarily strict design controls intended to significantly limit all potential risks to end users, beginning with those that could be introduced via the design, production and testing of board-level components. Clearly understanding and resolutely adhering to the regulatory stan- dards drafted and enforced by vast international organizations and governments, like the ISO and FDA, can be intimidat- ing and difficult though, even for engineers. However, when stripped down to their essentials, these dense, jargon-filled texts are nowhere near the headache you might expect. The FDA regulates medical devices according to the pro- visions of the Federal Food Drug and Cosmetic Act, which classifies several aspects of the design, manufacturing, packaging, labeling, clinical evaluation and post-market sur- veillance of these devices under the Title 21 Code of Fed- eral Regulations (CFR). Last updated in April of 2015, Part 820 – Quality System Regulation, Subpart C – Design Con- trols defines the various procedures that all Class II, Class III, and specific types of Class I medical component and device manufacturers must establish and rigorously main- tain to control the design of each device and ensure that all specified design requirements are met. Adherence to these controls effectively prevents commercial components that lack design- or change-control from being specified for use in medical devices due to the risks associated with undocu- mented process or material changes. These requirements were recently formalized in ISO 13485, a standalone regulatory document that's generally in line with ISO 9001. Originally published in 1996, and up - dated earlier this year (2016), ISO 13485 clearly explains the requirements for establishing and maintaining a comprehen - sive quality management system for the design and manu - facture of medical devices as prescribed in the Title 21 CFR. Each medical component and device manufacturer is now required to establish and maintain procedures for regulating design and development planning, in addition to design: in- put, output, review, verification, validation, transfer, changes and historic filing, which admittedly still sounds a little intim- idating, but can be quickly and easily summarized in just a handful of bullet points. • Design and Development Planning: Describe the com- ponent design and development process in step-by- step detail, clearly defining who is responsible for the implementation of each. • Design Input: Review the initial requirements for the medical component or device that you intend to produce to ensure that they're appropriate, and clearly explain the intended use of the component or device. • Design Output: Examine the final component or device specifications that resulted from your design and engineering efforts, and evaluate for conformance to design input requirements. • Design Review: Schedule and conduct formal docu- mented reviews of the design results at each stage of development. • Design Verification: Compare the design outputs to the design input requirements to confirm that the device was successfully designed and manufactured according to spec. • Design Validation: Test the component or device under actual or simulated use conditions, thoroughly docu- menting all testing procedures and results, and then evaluate said results to ensure that the component or device adequately fulfills the intended use. • Design Transfer: Carefully translate the device design into production specifications. • Design Changes: Explain how to identify, document, validate, verify, review, and approve design changes before they can be implemented in the medical com- ponent or device at hand. • Design History: Maintain a design history file (DHF) that contains all of the aforementioned documentation in order to demonstrate that the design was developed in accordance with the approved design plan and all relevant regulatory requirements. One of the best ways to keep track of whether a com- ponent design change requires customer notification and/ or adherence with regulatory requirements is to develop and utilize design decision templates. These documents can be populated with proprietary instructions that address each aspect of a component's design, manufacturing, and test- ing. Cheap and easy to implement, design decision tem- plates are an extremely effective way to both formalize a manufacturer's change control procedures and simplify the auditing and approval processes executed by medical de- vice manufacturers to ensure compliance with their change control procedures. A sample design decision template, which manufacturers can fill in with their own proprietary instructions for what action should be taken when and by whom to ensure compliance with ISO and FDA design control requirements.

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