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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71 BONEZONE • December 2016 • Ideal for applications where tissue pull-through may be a concern • Profile is 40% thinner than similar tapes* • Braid contours and lies flat against the surface • Gentle on tissue and gloves • Sizes 1mm to 5mm ©2016 Teleflex Medical OEM. All rights reserved. Teleflex, Force Fiber, OrthoTape, and "Work With The Experts" are registered trademarks or trademarks of Teleflex Incorporated in the U.S. and/or other countries. *Data on file. Force Fiber ® OrthoTape ® Braid W O R K W I T H T H E E X P E R T S ™ Low Profile. Broad Footprint. Ultra Strong, Yet Gentle. Our Braid's Performance Characteristics: Outstanding! trained to understand the new ISO Standard to vary- ing degrees. Yes, even the people who live in the stra- tegic company clouds and are not tactically involved in the day-to-day must be competently aware of what caused their "easy chairs" to be put into cold storage for a few months. They won't like it. Also, top level management must understand how risk management will challenge and stretch the fabric of their 2003 processes and the present way of doing business. "I still can't believe it, but it's been about 12 years since ISO 13485:2003 came into our lives and our company is real comfortable." Maybe too comfort- able, you say. Incorporation of risk-based approaches beyond product realization means that risk-based decision-making will eventually be part of making all quality-based decisions. (In case you aren't embrac- ing this major requirement just yet, this means that all sections of the new ISO Standard are affected, and not just Section 7.1 of Product Realization.) Also, risk continues to be considered in the context of the safety and performance of the medical device and in meet- ing regulatory requirements, e.g. submissions, post market surveillance, recalls, medical device reporting, vigilance reports, etc. Step 5: Ensure that Middle Managers are Positioned to Succeed Okay, you're right; this is not just for top level man- agement. On the contrary, some of the biggest chal- lenges for middle managers will at least include: • Incorporation of risk-based approaches beyond product realization – "Hip shots" aren't allowed any more. • Increased linkage with regulatory require- ments – This new standard is much like the cGMP-QS Regulations. ISO 13485:2016 specifi- cally asks us to ensure that we are evaluating both product and process changes. • Application to suppliers throughout the lifecycle and supply chain for medical devices – Here's a classic comment that I've heard: "Why do we have to make sure our suppliers have validated processes, when we can't even keep up with validating our own?" • Harmonization of software validation require- ments – There are more explicit requirements for software validation use throughout the QMS. • Emphasis on appropriate infrastructure, particularly for production of sterile medical devices. • The addition of requirements for validation of sterile barrier properties.

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