Forum

pd493
@pd493
Eminent Member
Joined: Jan 18, 2025
Last seen: May 6, 2025
Topics: 1 / Replies: 39
Reply
RE: Examples of budget changes due to DSD testing

The probability of having to change the budget for additional experiments during a verification test depends on several factors, 1) Strict protocols...

4 months ago
Reply
RE: Humanitarian Device Exemption

Yes, the prime concern in Human Device Exemption is Reasonable assurance of safety and Probable Benefits. The other problems are, 1) Safety and Risk-B...

5 months ago
Reply
RE: The Importance of the Design History File (DHF) in Regulatory Compliance

The design history file is an important part of medical device development. The FDA has certain rules for this file first, the DHF must include record...

5 months ago
Reply
RE: Critical Role of Design Controls in Medical Device Projects

Organizations can balance innovations and compliance by following a structured approach. They should focus on the high-risk areas. Focus on the most i...

5 months ago
Reply
RE: Handling Conflicts Among Team Members Effectively

I think project managers can handle conflicts by various strategies. 1) Setting up a hierarchy, so that teammates don't get confused in their roles....

5 months ago
Reply
RE: Caution with Medical Devices that Require a PMA

Yes, common practice can sometimes limit the creation and innovation of better medical products for several reasons: 1)Premarket Approval (PMA) must...

5 months ago
Reply
RE: Balancing Innovation with Compliance

The most significant regulatory challenge in developing emerging medical technologies is balancing innovation with patient safety and user acceptance....

5 months ago
Reply
RE: Managing Risks from External Dependencies

The manager can have various problems due to delayed supplies, damage during transport, and other factors. The issues can be dealt with tactically. Fi...

5 months ago
Reply
RE: Transitioning to New Technologies During an Ongoing Project

When new technologies emerge during a project, the manager must assess the impact and outcome carefully. The risks and benefits are weighed before pro...

5 months ago
Reply
RE: Design Verification Failures

If there is a failure the manager and team have to diagnose the problem whether it is the failed design verification test, the actual device failure, ...

5 months ago
Page 3 / 3