Are you wondering what's new in the latest version of ISO 9001? The simple answer is, "Just about everything." This article summarizes the major changes, with tools and strategies to help you revise and update your quality system documentation.
Fees for 510(k) submissions increased by $210 standard and $105 for a small business; PMA fees increased by $10,493 and $2,623, respectively. The increased rates go into effect October 1.

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From regulatory changes to working with new materials and technologies, many aspects of the device testing process can hold up orthopaedic device manufacturers. Keeping an open and strong line of communication between your testing supplier and FDA consultant is critical to meeting requirements.
Despite the growing use and adoption of disposable instruments, reusable instruments still dominate the orthopaedic market. Gibraltar Laboratories' Jozef Mastej outlines the cleaning and sterilization validation process for reprocessing reusable devices. 

Congratulations! Your company just received the Registration Certificate for your new trademark. Now what do you do? A best practice would be to create a guide on its proper use to share with marketing, sales and communications departments.  
High growth segments, additive manufacturing, small and smart companies - all are positively received by investors, which in turn fuels deals. Register for a 30-day trial of ORTHOKNOW® to read more and view a table providing perspective on each of the 24 closed or slated-to-close acquisitions for 2015. Transactions are classified by OEMs acquiring OEMs, OEMs acquiring partners and suppliers acquiring suppliers. 30-day trial
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MX Orthopedics received FDA clearance to market the dynaMX™ Compression Staple, featuring Malleable Nitinol Technology.

Smith & Nephew acquired the trauma and orthopaedics business of DeOst, which has distributed SNN products in Russia since 2009.

DePuy Synthes/Johnson & Johnson posted 2Q15 orthopaedic sales of US $2,330MM, +0.9% vs. 2Q14.

Bacterin closed its purchase of X-spine Systems for ~4.24MM shares of common stock and ~US $60MM in cash.

Ortho Regenerative Technologies entered into an agreement to acquire a biopolymer platform technology for repair and regeneration of damaged joints. 

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