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Articles Tagged "orthopaedic regulations"

Trade Secrets Go Federal

by BONEZONE | Jun 2016

Passage of the "Defend Trade Secrets Act" (DTSA) federalized the trade secret law. One of the key aspects of DTSA is that companies will now be allowed to file civil lawsuits in Federal court if their trade secrets have been stolen, possibly creating a new level of consistency in how trade secret la... Read more »

FDA Releases Final Guidance on Human Factors and Usability Engineering

by BONEZONE | Apr 2016

The Agency released the final guidance on considerations for human factors data in premarket submissions, as well as two draft guidances on the topic.... Read more »

FDA Launches Searchable UDI Database

by BONEZONE | Jun 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 »

Standard, Sterile and Small: Packaging Trends Focus on Savings and Speed to Market

by Carolyn LaWell | Mar 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 »

ISO 55000 Released to Assist Operations Leaders with Financial Management

by Randy W. Rapin | Jan 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 »

Unique Device Identification (UDI): Many Questions Remain

by Karen Conway | Dec 2014

FDA issued its final rule requiring medical device manufacturers to assign and label products with UDIs more than a year ago. However, many questions remain for orthopaedic and spine manufacturers.... Read more »

FDA Clarifies Substantial Equivalence Requirements for 510(k) Submissions

by Justin Rowland | Sep 2014

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 »

How Far is “Possible” for Risk Management?

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 »

Medical Device Excise Tax: Achieving Compliance with Confidence

by David Emmons | Oct 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 »

Medical Device Excise Tax - OMTEC 2012 Opening Panel Discussion

by BONEZONE | Jul 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 »

FDA and industry reach agreement in principle on medical device user fees

by BONEZONE | Mar 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 »