What if Your ISO Auditor is Wrong?
Auditors are human. The question is: What should you do when they're wrong? Apr 17 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,
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 complaint. These steps lead to a successful investigation process. Jun 06 2013,
Lessons Learned From Metal-on-Metal Implants
The FDA is only the latest regulatory body to take investigative action on metal-on-metal implants. What follows is a two-part primer on metal implant test method results and risk analysis steps OEMs should consider as fallout continues over the use of MoM implants. Mar 05 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 roadmap to certification. May 06 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 sooner. Sep 03 2013,
The Anatomy of a Successful Design Plan
Did your latest project plan end with another line extension and the cold reality that your team was eight weeks behind? These six steps will allow you to master the design and construction of medical device design planning. Oct 02 2013,
How to Build a Better Supplier Scorecard
Supplier scorecards are intended to be a simple tool to help you evaluate suppliers. These steps provide for an easier and more efficient process. Nov 06 2013,
Start Early: Converting Your Spinal Technical File into a Class III Design Dossier
As part of EU Commission regulatory changes, spinal implants will be reclassified from Class IIb devices to Class III devices. OEMs with spinal implants on the market should be proactive and start planning for reclassification now. Dec 11 2013,
Auditing Process Validation & Developing Protocols
Have you ever had to perform a process validation protocol for a new piece of equipment or acquired a process that was not properly validated? If not, consider yourself lucky. For when the task does arise, here is how to perform a process validation audit and develop a protocol. Jan 15 2014,