Need Some Help?
For years, MD&DI's Help Desk has been finding answers to reader questions about the design, development, manufacture, and marketing of medical devices. Here's a list of topics that have been covered in the past:
Pyrogenicity Testing; EtO Sterilization
EtO and Plastic Bags; Shrink-Wrap versus Netting; Is Cyclohexanone Safe for Bonding?
Issuing Product Certificates for CE Marking
Addressing FDA's Concerns about Electromagnetic Interference
Submitting a 510(k) for Changes in Device Design
Choosing Discrete-Event Simulation Software
Device Sterility Guidances and Validation
How to Handle Increased Production Volumes
Standards and Methods for Using EtO
EtO Sterilizers Must Revalidate When Changing Their Procedures
Biocompatibility Testing Is Needed Despite Material Supplier Claims
Using Patents to Secure Rights to Concepts and Inventions
Process Validation Requirements for Drugs and Devices
Choosing Strategic Stocking Locations
Developing a Successful Employee Training Program
Effective Training for New Manufacturing Employees
Determining the Size of a Medical Device Market
How to Schedule Verification and Validation
The Differences between U.S. and E.U. Laser Standards
Determining Sample Size for Testing Equivalence
Clarifying Device History Record Issues
Establishing a Supply Agreement That Benefits Both Parties
CE Marks/IVD Directive, Computer Issues, and Complaint Rate Data versus Risk Analysis
Software Can Help Manage Clinical Trials
