Thanks! You've successfully subscribed to the BONEZONE®/OMTEC® Monthly eNewsletter!

Please take a moment to tell us more about yourself and help us keep unwanted emails out of your inbox.

Choose one or more mailing lists:
BONEZONE/OMTEC Monthly eNewsletter
OMTEC Conference Updates
Advertising/Sponsorship Opportunities
Exhibiting Opportunities
* Indicates a required field.

Articles Tagged "21 cfr"

FDA and Customs Monitoring of International Purchasing: What You Need to Know

by BONEZONE | Apr 2018

The ultimate goal is to ensure that all medical device products manufactured or distributed in the U.S. are both safe and effective for human use. ... Read more »

Class II Design Problem Solved with Simulation

by Eric Lintula | Oct 2016

Many articles generalize design controls, but few provide direct application. This article offers a broad overview for engineers and their managers to highlight the milestones of a design process from design request to purchase order, using Finite Element Analysis.... Read more »

Making Smarter Product Recall Decisions: 4 Critical Steps to Meeting FDA’s Expectations

by Martin Browning | Dec 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »