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Articles Tagged "purchasing controls"

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 »

Value Analysis Committees: Develop Your Own

by BONEZONE | Aug 2017

The influence of hospital VACs has created a market access risk that you must consider when assessing new technologies—before product development begins. How do you reduce that risk? One idea is to create your own panel of experts—or at the very least, interview experts—that extend beyond the ... Read more »

Supplier Quality Agreements Are Not Just a Handshake Anymore

by BONEZONE | Apr 2016

Regulatory bodies do not see supplier quality agreements as a new requirement. They also expect medical device manufacturers to require suppliers to conduct remediation where required and within documented timelines. It is appropriate to use a risk management approach to prioritize required focal po... Read more »

FDA Outlines Critical Quality Measures

by BONEZONE | Sep 2015

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 »

Purchasing Controls: Draft the Best Supplier Quality Agreement

by John Gagliardi | Jul 2015

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 »

BONEZONE Authors Present Solutions at OMTEC 2013

by BONEZONE | Apr 2013

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 »