FDA Finalizes UDI Requirements
Final rule does not mandate direct part marking for implantable devices, provides manufacturers of Class III implants one year to...
Sep 24 2013,
Regulations
How to Choose a Notified Body
The right Notified Body will support device manufacturers in accomplishing current and long-term goals. Here are questions to ask and...
Sep 10 2013,
Postmarket Studies in Lieu of Clinical Trials
A strategic combination of premarket and postmarket clinical studies proactively establishes a process to identify design problems and generate revenue...
Sep 03 2013,
India Considering New Device Regulations
With an evolving regulatory situation, medical device companies must stay up-to-date in order to achieve success in India. Orthopaedic OEMs...
Aug 05 2013,
China Becomes Vastly Improved Player
China’s medical device market is growing fast and the competition is fierce. Companies looking to enter the market or expand...
Jul 10 2013,
How to Avoid Major FDA Inspection Mistakes
Don’t let these details get lost in the preparation and follow up for FDA inspections....
Jul 10 2013,
UDI Update: Prepping for the Final Ruling
OEMs should be asking, and answering, these 11 questions in anticipation of FDA’s final ruling on UDI guidelines....
Jul 10 2013,
The Race to the Patent Office Is On
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...
Jun 06 2013,
Seven Ways to Investigate Complaints When Devices Aren’t Returned
One of the challenges in product complaint handling is making sure you’ve done enough when you’re unable to verify the...
Jun 06 2013,
Navigating the Clinical Research Paradigm for Cost Savings and Efficiencies
By working effectively through the timelines and deliverables from reimbursement, the regulatory pathway, data requirements and clearance, companies can bring...
May 08 2013,
Design Control Hot Buttons to Expect During an FDA Inspection
FDA evaluates the methods and procedures that a manufacturer has established to implement design control requirements. During an inspection, attention...
May 07 2013,
Six Steps to ISO 13485 Certification
ISO 13485 Certification is the quickest pathway to achieving CE Marking approval. Manufacturers should follow these sequential steps as a...
May 06 2013,
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....
Apr 17 2013,
What if Your ISO Auditor is Wrong?
Auditors are human. The question is: What should you do when they're wrong?...
Apr 17 2013,
Just Because You’re Trained, Doesn’t Mean You’re Competent
Orthopaedic device manufacturers must define the requirements for each job, evaluate the people in those jobs, develop a gap examination...
Apr 17 2013,