Mitigate Patent Infringement Risk with an FTO
Performing an FTO search is a critical tool when developing or getting ready to launch a new product. Here's how...
Performing an FTO search is a critical tool when developing or getting ready to launch a new product. Here's how...
The success of a risk management process in medical device manufacture lies in an early start in design and use...
Shifts in the marketplace are driving a need to collect and position clinical data in order to show product effectiveness....
Final rule does not mandate direct part marking for implantable devices, provides manufacturers of Class III implants one year to...
The right Notified Body will support device manufacturers in accomplishing current and long-term goals. Here are questions to ask and...
A strategic combination of premarket and postmarket clinical studies proactively establishes a process to identify design problems and generate revenue...
With an evolving regulatory situation, medical device companies must stay up-to-date in order to achieve success in India. Orthopaedic OEMs...
China’s medical device market is growing fast and the competition is fierce. Companies looking to enter the market or expand...
Don’t let these details get lost in the preparation and follow up for FDA inspections....
OEMs should be asking, and answering, these 11 questions in anticipation of FDA’s final ruling on UDI guidelines....
New regulations have converted U.S. patent law from a “first-to-invent” to a “first-inventor-to-file” system. These best practices will ensure you...
One of the challenges in product complaint handling is making sure you’ve done enough when you’re unable to verify the...
By working effectively through the timelines and deliverables from reimbursement, the regulatory pathway, data requirements and clearance, companies can bring...
FDA evaluates the methods and procedures that a manufacturer has established to implement design control requirements. During an inspection, attention...
ISO 13485 Certification is the quickest pathway to achieving CE Marking approval. Manufacturers should follow these sequential steps as a...
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