BONEZONE

DEC 2016

Published by ORTHOWORLD Inc., BONEZONE delivers strategic sourcing & product commercialization solutions to orthopaedic device company decision makers and their partners.

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69 BONEZONE • December 2016 QUALITY MANAGEMENT Here are several ISO 13485 changes that you will need to include in your bridge construction: • Medical Device File (a.k.a., a Device Master Record) – You're now expected to include a description of each medical device or family of devices, and include all associated specifications, procedures and records. • Record Keeping – The new standard expects you to record supplier monitoring and re-evaluation activi- ties and to consider privacy regulations when you develop methods for protecting confidential health information. • Product Realization – The expectation is that you establish product handling, storage, measuring, revalidation and traceability requirements. • User Training – The requirement wants you to think about the safety and performance of your products and the associated training needs of product users, as well as verify that regulatory requirements will be met and user training will be available before you agree to supply products to customers. • Design Inputs – You must consider risk manage- ment outputs to clarify product usability and safety requirements, and to make sure that input require- ments can be verified or validated. • Design Verification and Validation – Simply put, this design controls change expects you to verify that design outputs meet input requirements when these devices are connected or interfaced, and to validate that intended use or application requirements are met when devices are connected or interfaced. • Design Changes – ISO now asks you to establish processes to control changes and to evaluate their sig- nificance and impact. It also expects you to maintain a file for each medical device or family of medical devices that documents these changes. • Design Transfer – This subject has been elevated in importance and has now received its own subsection, i.e., a special emphasis is given to ensure that outputs are suitable for manufacturing before they become official production specifications. • Purchasing – You now need to consider your medical device and the risk you're taking in addition to the effect that purchased products have on the safety and performance of your medical device. You want to

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