Below are links to a number of articles that Rob Packard, President of Medical Device Academy, has written for BONEZONE journal.
-
- Top Tools to Qualify Suppliers. January 11, 2017
- ISO 9001 Drastically Revised, August 11, 2015
- Big Changes in ISO 13485:2015?, May 12, 2015
- The Basics: Understanding the Medical Device Single-Audit Program (MDSAP) Pilot, February 10, 2015
- Sterilization: How to Validate Novel and Non-Traditional Processes, April 11, 2014
- How Far is “Possible” for Risk Management?, April 9, 2014
- 5 Ways to Prevent Complaint Handling Pitfalls, March 5, 2014
- Auditing Process Validation & Developing Protocols, January 15, 2014
- Device Company ISO Questions Answered, December 11, 2013
- Start Early: Converting Your Spinal Technical File into a Class III Design Dossier, December 11, 2013
- How to Build a Better Supplier Scorecard, November 6, 2013
- The Anatomy of a Successful Design Plan, October 2, 2013
- Post-Market Studies in Lieu of Clinical Trials, September 3, 2013
- How to Avoid Major FDA Inspection Mistakes, July 10, 2013
- Seven Ways to Investigate Complaints When Devices Aren’t Returned, June 6, 2013
- Six Steps to ISO 13485 Certification, May 6, 2013
- What if Your ISO Auditor is Wrong?, April 17, 2013
- Lessons Learned From Metal-on-Metal Implants, March 5, 2013
- Develop Orthopaedic Implants Faster Through Auditing, February 13, 2013
- Six Steps to Qualifying Suppliers, January 16, 2013
- Strategic Planning for Regulatory Compliance, December 13, 2012