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,
Regulations
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,
Get Ready for UDI: It’s All About the Data
Orthopaedic OEMs will be among the first to comply with FDA's unique device identification requirements once finalized. However, the complex...
Mar 05 2013,
FDA Releases New Requirements for Combination Products
FDA's final rule on cGMP for combination products provides a definition of these products and the new requirements....
Mar 05 2013,
ASTM Names New Standard for Raw Materials
ASTM added a PEKK raw material standard for medical device implants that if met, will reduce the testing needed to...
Mar 05 2013,
Trademarks vs. Domain Names, Part II: There is a BIG Difference
What happens if your trademark or company brand becomes a victim of cybersquatting? Part II on trademarks vs. domain names...
Feb 13 2013,
Rethinking the Role of Clinical Affairs
“Clinical” has become virtually synonymous with Investigational Device Exemption and Premarket Approval. Really, clinical affairs should be viewed as a...
Feb 13 2013,
Passing Brazil’s Inspections to Take Product to Market
Over the past few years, I have had the opportunity to help orthopaedic medical device companies prepare for and logistically...
Jan 16 2013,
Making Smarter Product Recall Decisions: 4 Critical Steps to Meeting FDA’s Expectations
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...
Dec 17 2012,
The Quality Review Board: A Conduit for Success
Your Quality Review Board exists to ensure continual improvement to your Quality Management System. How do they stack up as...
Dec 17 2012,