FDA Recognizes Computer Simulated Performance Data in Device Evaluation
FDA seeks to draft verification and validation guidelines in response to more medical device manufacturers using computer modeling and simulation....
FDA seeks to draft verification and validation guidelines in response to more medical device manufacturers using computer modeling and simulation....
Auditors are human. The question is: What should you do when they're wrong?...
Orthopaedic device manufacturers must define the requirements for each job, evaluate the people in those jobs, develop a gap examination...
Orthopaedic OEMs will be among the first to comply with FDA's unique device identification requirements once finalized. However, the complex...
FDA's final rule on cGMP for combination products provides a definition of these products and the new requirements....
ASTM added a PEKK raw material standard for medical device implants that if met, will reduce the testing needed to...
What happens if your trademark or company brand becomes a victim of cybersquatting? Part II on trademarks vs. domain names...
“Clinical” has become virtually synonymous with Investigational Device Exemption and Premarket Approval. Really, clinical affairs should be viewed as a...
Over the past few years, I have had the opportunity to help orthopaedic medical device companies prepare for and logistically...
FDA’s multi-layered rules for product recalls can resemble a double-edged sword. Have you under-reported your recall? Over-reported? How can you...
Your Quality Review Board exists to ensure continual improvement to your Quality Management System. How do they stack up as...
What happens if there is a dispute over the use of your domain name, or if someone is using your...
Will you wait until your company has an unannounced audit by a Notified Body? Or will you develop a Quality...
On August 13, 2012, FDA issued a draft guidance, “Refuse to Accept Policy for 510(k)s.” This guidance explains procedures and...
Monetizing intellectual property is the process of deriving tangible value from the IP or the technology that is protected by...
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