According to the U.S. Department of Health & Human Services OIG(office of inspector general), the Anti-Kickback Statute was originally enacted in 1972 to protect patients and federal healthcare programs from fraud and abuse. The federal Anti-Kickback Statute (“Anti-Kickback Statute”) is a criminal statute that prohibits the exchange (or offer to…[Read more]

This is one of the qualitative course which i took in this semester. I would like to evaluate myself From being a naive to Industrial exposure to basic knowledge holder after learning from this course. The main thing i like about this course is it start from the scratch, no prerequisites.Secondly, the well arranged structure of the course was more…[Read more]

Labeling of medical devices is important, both to enable the manufacturers of the devices to meet
the requirements for device tracking using serial numbers and to enable customers in the clinical setting to
identify and properly employ the devices.

Risk management is the process of combining a risk assessment with decisions on how to address that risk, and doing so in ways that consider the technical and social aspects of the risk assessment. Risk management is part of a larger decision process that considers the technical and social aspects of the risk situation. Risk assessments are…[Read more]

Hi Viraj,

A good point to discuss. Here i am sharing my views after a research on the topic. According to that research there are few steps as below,
1- Documentation Reviews
2- Information Gathering Techniques like Brainstorming, Delphi Technique, Interviewing, Root cause analysis
3- Checklist analysis – previous similar project, lowest level…[Read more]

Hi Himang,

Although i don’t have experience but i do research and from that I know the following:
There is usually a chairperson who is responsible for coordinating the preparations for the design review and managing the review meeting.
A design team (usually engineers) whose responsibility is to provide details regarding the design and its…[Read more]

Hi Himang,

Design controls are a component of a comprehensive quality system that covers the life of a device.Design control begins with development and approval of design inputs, and includes the design of a device and the associated manufacturing processes. Design control does not end with the transfer of a design to production. Design control…[Read more]

Hi Lamiaa,
A good topic to start a discussion. The main consequence is the failure of that product in market.Here i would like to give some examples recently happened though they are not related to medical devices but i think they are suitable to the topic and they all are the results of insufficient design control.

First one is Samsung Note 7…[Read more]