Medical Device Courses | kbs27 | Activity https://medicaldevicecourses.com/members/kbs27/activity/ Activity feed for kbs27. Fri, 24 Apr 2026 17:08:51 -0400 https://buddypress.org/?v= en-US 30 hourly 2 bfa2e199589ecf2486719d6d9c604fe0 kbs27 replied to the topic "Anti-kickback & Stark Cases" - https://medicaldevicecourses.com/activity/p/11339/ Wed, 15 May 2019 16:44:02 -0400 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to the U.S. Department of Health & Human Services OIG(office of inspector general), the Anti-Kickback Statute was originally enacted in 1972 to protect patients and federal healthcare programs from fraud and abuse.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…   Read more»

]]> d32efb32e9c4262a17ab2c4042d30553 kbs27 replied to the topic "Discussion Topic: Course conclusion and impressions" - https://medicaldevicecourses.com/activity/p/11338/ Wed, 15 May 2019 16:44:02 -0400 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…   Read more»

]]> c706b422d298061930159e3067307262 kbs27 replied to the topic "Risk management and Labels" - https://medicaldevicecourses.com/activity/p/11098/ Wed, 15 May 2019 16:39:53 -0400 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.

]]> 391d4d06f1e1f632c1226ee9a64d8a7f kbs27 replied to the topic "Discussion Topic: Risk Management, Risk Analysis" - https://medicaldevicecourses.com/activity/p/11097/ Wed, 15 May 2019 16:39:53 -0400 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…   Read more»

]]> 0b13eebf4a25fa2a04b9dce158752309 kbs27 replied to the topic "Risk Identification" - https://medicaldevicecourses.com/activity/p/11090/ Wed, 15 May 2019 16:39:49 -0400 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,…   Read more»

]]> 2b3bc680954d1067b920ab7e44a14438 kbs27 replied to the topic "Design Review Meetings" - https://medicaldevicecourses.com/activity/p/10940/ Wed, 15 May 2019 16:38:08 -0400 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…   Read more»

]]> 6bb262423c588cdd307658192298d17a kbs27 replied to the topic "What are Design Controls?" - https://medicaldevicecourses.com/activity/p/10823/ Wed, 15 May 2019 16:36:55 -0400 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….   Read more»

]]> 552bc9c0b1c2f9f0a3275ab5d66bbe23 kbs27 replied to the topic "Consequences Of Insufficient Design Controls" - https://medicaldevicecourses.com/activity/p/10822/ Wed, 15 May 2019 16:36:54 -0400 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…   Read more»

]]> fc1acb603422f80953bc571075b4d6e9 kbs27 posted a new topic "Written Agreement v/s Verbal Agreement" - https://medicaldevicecourses.com/activity/p/10417/ Wed, 15 May 2019 16:33:24 -0400 Hi all, In the video lecture Dr.Simon mentioned about two terms of contract,Written & Verbal agreement. He said that verbal contract can be legal but what if the due to dispute or other reason the verbal agreement turns to failure….   Read more»

]]> b80b50bf66b340327032379861d6afa8 kbs27 posted a new topic "Design Transfer and Challenges" - https://medicaldevicecourses.com/activity/p/10387/ Wed, 15 May 2019 16:33:06 -0400 Design transfer which is an integral process in the early life of a product, it must be well executed for complex medical devices.And as Professor mentioned if it satisfies the FDA quality rules & regulations, the product undergoes the production….   Read more»

]]> 19495eb1885055ddd02bc0a884389650 kbs27 replied to the topic Anti-kickback & Stark Cases in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/822/ Wed, 30 Nov 2016 21:03:15 -0500 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]

]]> 0 9c5caa29f52de1c7077505ceb85a7b37 kbs27 started the topic Written Agreement v/s Verbal Agreement in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/821/ Wed, 30 Nov 2016 20:49:58 -0500 Hi all,

In the video lecture Dr.Simon mentioned about two terms of contract,Written & Verbal agreement. He said that verbal contract can be legal but what if the due to dispute or other reason the verbal agreement turns to failure. Is there any significant difference between Verbal Agreement & Oral Agreement? How much one should rely on verbal…[Read more]

]]> 0 c067cad45e90bedc5e7d52bef38a9b10 kbs27 replied to the topic Discussion Topic: Course conclusion and impressions in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/820/ Wed, 30 Nov 2016 20:39:20 -0500 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]

]]> 0 0dbaa5e0335624a029af571020272476 kbs27 replied to the topic Risk management and Labels in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/518/ Thu, 17 Nov 2016 19:01:44 -0500 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.

]]> 0 6aa3564c58624cdfe4bbc5b8338da193 kbs27 replied to the topic Discussion Topic: Risk Management, Risk Analysis in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/517/ Thu, 17 Nov 2016 18:47:46 -0500 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]

]]> 0 9fc02f5067ffe6894259a70e0c73ac97 kbs27 replied to the topic Risk Identification in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/507/ Wed, 16 Nov 2016 20:23:27 -0500 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]

]]> 0 4d625a779fbd7e7a1b8480adc269eee0 kbs27 replied to the topic Design Review Meetings in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/310/ Wed, 09 Nov 2016 22:26:43 -0500 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]

]]> 0 0787a622eb490bc9c1296722c09d8b63 kbs27 started the topic Design Transfer and Challenges in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/288/ Tue, 08 Nov 2016 15:18:11 -0500 Design transfer which is an integral process in the early life of a product, it must be well executed for complex medical devices.And as Professor mentioned if it satisfies the FDA quality rules & regulations, the product undergoes the production.
There are some factors which can fail the Design transfer process like business style, difference in…[Read more]

]]> 0 c5f595ad5128229e01d1b242fe9d64a0 kbs27 replied to the topic What are Design Controls? in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/129/ Fri, 04 Nov 2016 03:58:18 -0400 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]

]]> 0 340770e1799672c13b3678f8461f9c9c kbs27 replied to the topic Consequences Of Insufficient Design Controls in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/128/ Fri, 04 Nov 2016 03:48:55 -0400 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]

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