Medical Device Courses | ppp23 | Activity https://medicaldevicecourses.com/members/ppp23/activity/ Activity feed for ppp23. Fri, 24 Apr 2026 20:59:24 -0400 https://buddypress.org/?v= en-US 30 hourly 2 dbdcd73f50f6ca174d396d49c12b345f ppp23 replied to the topic "Recent Examples of Kickback Allegations" - https://medicaldevicecourses.com/activity/p/14417/ Wed, 15 May 2019 18:55:56 -0400 As announced on Monday, October 17, 2016, by the United States Department of Justice (“DOJ”), the nation’s largest nursing home pharmacy, Omnicare Inc. (a CVS Health company), has agreed to pay $28.125 million to resolve allegations that it solicited and…   Read more»

]]> 02e14bb0698ad9a3ef611fa3eb4a381e ppp23 replied to the topic "NDA vs Patents" - https://medicaldevicecourses.com/activity/p/14363/ Wed, 15 May 2019 18:55:29 -0400 NDAs offer a standout amongst the most surefire approaches to protect trade secrets and other private data intended to be kept under wraps. Data normally protected by NDAs may incorporate schematics for another item, customer data, deals and promoting plans,…   Read more»

]]> 25d1f47e3475ab902aaaa4e524f86aed ppp23 replied to the topic "Discussion Topic: Course conclusion and impressions" - https://medicaldevicecourses.com/activity/p/14362/ Wed, 15 May 2019 18:55:28 -0400 Dr Simon, I have learned a lot from this course. It gave me knowledge about the Regulatory affairs, Quality Control and Quality Assurance. It has helped me put the knowledge at work and I have been using your presentations to…   Read more»

]]> 768dbe97aa3d70c0e9ad1531f81fbdaf ppp23 replied to the topic "Organization types of medical devices?" - https://medicaldevicecourses.com/activity/p/14316/ Wed, 15 May 2019 18:55:03 -0400 I would prefer to have a matrix organization because : Assets are utilized effectively and can move around between projects as required. You can chip away at loads of various things, once in a while in parallel—despite the fact that…   Read more»

]]> 528671905d42ed234496c1730ef6736c ppp23 replied to the topic "Forming a Project Team" - https://medicaldevicecourses.com/activity/p/14266/ Wed, 15 May 2019 18:54:35 -0400 Forming a project team is not an easy job. I would recommend to avoid following mistakes: Mistake #1: Not meeting with the whole team and setting goals upfront “It’s important for the entire team to know roles and responsibilities and…   Read more»

]]> 3161175a26be95b85b11e16f989069ec ppp23 replied to the topic "Discussion Topic: Your organizational type" - https://medicaldevicecourses.com/activity/p/14265/ Wed, 15 May 2019 18:54:34 -0400 I would like to work for matrix organization because matrix management is ideal for sharing talents and skills across departmental boundaries. One of the most common scenarios for matrix management is when a group of individuals from all different functions…   Read more»

]]> d10304e184f9d621f297d0d8b5fec91c ppp23 replied to the topic "Manage Risk" - https://medicaldevicecourses.com/activity/p/14202/ Wed, 15 May 2019 18:52:59 -0400 Responding to the various categories of risk There are four basic responses available to businesses depending on the category a given risk is placed: Accept the risk as a cost of doing business, and decide to retain and budget for…   Read more»

]]> f1a709fca80f1bf5f6063d88a64cd516 ppp23 replied to the topic "how far is "As Far As Possible"" - https://medicaldevicecourses.com/activity/p/14200/ Wed, 15 May 2019 18:52:59 -0400 The best place to start is the traditional risk matrix. The underlying concept of ISO 14971:2007 is to estimate risk (the output of Risk Analysis in Clause 4), evaluate the estimate against the acceptability criteria (in Clause 5), and determine…   Read more»

]]> f16bd130aa2db855c09023ed6cb89ac4 ppp23 replied to the topic "What is Risk-benefit analysis ?" - https://medicaldevicecourses.com/activity/p/14199/ Wed, 15 May 2019 18:52:58 -0400 The benefit-risk factors may be considered when device manufacturers evaluate appropriate responses to nonconforming product or regulatory compliance issues, such as determining whether to limit the availability of a medical device (e.g., a voluntary recall or market withdrawal). FDA may…   Read more»

]]> 9f4dc64add51dae70cc286eeef812cb4 ppp23 replied to the topic "Design Review Meetings" - https://medicaldevicecourses.com/activity/p/13985/ Wed, 15 May 2019 17:10:10 -0400 The Design Review process helps with other challenges of an engineering team like: Inter-org communication. Often people don’t know what other folks are working on. With very large teams you might even have two different engineers working on the same…   Read more»

]]> 40357be140de0e914ddf56b40e9956ec ppp23 replied to the topic "Factors to Consider While making Gantt Chart" - https://medicaldevicecourses.com/activity/p/13984/ Wed, 15 May 2019 17:10:09 -0400 bunch of tips and how-to tricks from several experienced project managers. Start date, end date, duration: Track it all The best way to track an ongoing project is using a Gantt chart. One important advantage of these charts is that…   Read more»

]]> a2b04dc026f9478d6cc57c12ecb12c33 ppp23 replied to the topic "Design input sources" - https://medicaldevicecourses.com/activity/p/13982/ Wed, 15 May 2019 17:10:08 -0400 Design inputs are the foundation of medical device development. And without a strong foundation, bringing a new product to market can be problematic. Call them what you want (design inputs, design requirements, design and development inputs, etc.), getting your design…   Read more»

]]> 3a7a1325438e6f79ea1752624865ec9c ppp23 replied to the topic "How to ensure your DHF is audit ready ?" - https://medicaldevicecourses.com/activity/p/13851/ Wed, 15 May 2019 17:08:48 -0400 Five Tips for Passing Your FDA Audit with Confidence Passing a regulatory audit is the first priority of any manufacturer of medical devices. It can be an especially scary time for startup firms. All three medical device startups agree that…   Read more»

]]> 7614015ca8e80fdaaf0051184db00f84 ppp23 replied to the topic "Consequences Of Insufficient Design Controls" - https://medicaldevicecourses.com/activity/p/13849/ Wed, 15 May 2019 17:08:47 -0400 Let’s dive deeper into why your design controls and risk management processes may be failing, and discuss what you can do about it. 1. Poorly Defined Product Development Processes — A medical device product development process needs to establish the…   Read more»

]]> 7b9658d18ad5c0c5058aa468bf7d4087 ppp23 replied to the topic "What FDA Looks For In A Design Control System ?" - https://medicaldevicecourses.com/activity/p/13848/ Wed, 15 May 2019 17:08:46 -0400 HI All, While reading through the FDA Design Control Guidance pdf, I came across this section, Can someone answer the following two Q’s? The quality system requirements for design output can be separated into two elements: Design output should be…   Read more»

]]> 8b07fac2a5dfac19f7a4140a9b88ef5e ppp23 replied to the topic "Double Blind Vs Single blind Study" - https://medicaldevicecourses.com/activity/p/13760/ Wed, 15 May 2019 17:07:58 -0400 Double blind procedure is a method of enhancing internal validity in an experiment. In double blind procedure, neither the researcher nor the subjects are made aware of which group is the experimental group and which the control group. In double…   Read more»

]]> 05f3b6fa60f8d126502a8fecb69be956 ppp23 replied to the topic "Clinical Trial Roles" - https://medicaldevicecourses.com/activity/p/13660/ Wed, 15 May 2019 17:07:00 -0400 I would like to Sponsor a clinical research. The reasons are as follows: 1. Selecting a clinical investigator 2. Monitoring the research 3. Ensuring clinical trial is being conducted as per the protocol and regulations 4. Making sure that investigators…   Read more»

]]> f8b8fb36e84a7c77342abe59f7cd76bb ppp23 replied to the topic "Clinical Studies" - https://medicaldevicecourses.com/activity/p/13659/ Wed, 15 May 2019 17:07:00 -0400 Hi All, Please read below the pros and cons of clinical studies. Pros 1. You may get promising new treatment methods that you can’t get outside clinical research. 2. The new method may have less side effects than the usual…   Read more»

]]> 4b72213b27ba1844d86696c60c1a2d93 ppp23 replied to the topic "Fuzz before launch of product." - https://medicaldevicecourses.com/activity/p/13568/ Wed, 15 May 2019 17:06:08 -0400 4 STEPS TO A SUCESSFUL PRODUCT LAUNCH The top four challenges faced by a new medical device product launch team are planning, communications, implementation, and follow-up. To achieve a successful medical device launch, all disciplines involved with the new device…   Read more»

]]> f670a798e836de3950eb6c653a84c910 ppp23 replied to the topic "Discussion Topic: Emotional Intelligence and its affect on sales" - https://medicaldevicecourses.com/activity/p/13567/ Wed, 15 May 2019 17:06:07 -0400 https: // http://www.mindtools.com/ pages/ article/ newCDV_59.htm

]]> 923e01e3517d0897da2e18b1f68fa84a ppp23 replied to the topic "Discussion Topic: Emotional Intelligence and its affect on sales" - https://medicaldevicecourses.com/activity/p/13566/ Wed, 15 May 2019 17:06:07 -0400 For some reason I am unable to add the reference link

]]> 6eb04b62e7d21f3cf067d51303a6389e ppp23 replied to the topic "Discussion Topic: Emotional Intelligence and its affect on sales" - https://medicaldevicecourses.com/activity/p/13565/ Wed, 15 May 2019 17:06:06 -0400 What Is Emotional Intelligence? We all have different personalities, different wants and needs, and different ways of showing our emotions. Navigating through this all takes tact and cleverness – especially if we hope to succeed in life. This is where…   Read more»

]]> c4e7ff6e5ee65477d0de894140e42dc7 ppp23 replied to the topic "Corporate Veil" - https://medicaldevicecourses.com/activity/p/13504/ Wed, 15 May 2019 17:05:28 -0400 Piercing the Corporate Veil Terms: Corporate Veil The corporate veil is the liability shield that inherently attaches to the shareholders of a corporation. In general, shareholders of a corporation are not personally liable for corporate debts or for torts committed…   Read more»

]]> 27b3c43fc7ca1485b1dfcb16d6c64f97 ppp23 replied to the topic "Accepting job based on company." - https://medicaldevicecourses.com/activity/p/13502/ Wed, 15 May 2019 17:05:27 -0400 Hi I would like to share my experience on why I turned down an offer: About 4 years ago, I got an offer for a position that was an ideal fit for my aptitudes and objectives. Also, the organization would…   Read more»

]]> 673f519f81ce1c44aca6ff572575bc62 ppp23 replied to the topic "Types of Corporations" - https://medicaldevicecourses.com/activity/p/13494/ Wed, 15 May 2019 17:05:23 -0400 Hi I would like to be an owner of a LLC for following reasons: Limited Liability Companies (LLCs) are flexible — you can use them for practically any purpose — and they offer more benefits than any other entity type….   Read more»

]]> 4d8dcff7ea02f79de9ee441abc8f6e0c ppp23 replied to the topic "Your Ideas about Improving Quality Control" - https://medicaldevicecourses.com/activity/p/13284/ Wed, 15 May 2019 17:03:36 -0400 Quality is the one attribute any manufacturer cannot hide – it screams who they are louder than any marketing campaign or PR strategy. Nothing says more about a manufacturer than how they prioritize quality management in manufacturing and information, intelligence,…   Read more»

]]> ea4e8c3d730f5959984b0ba55ce8fbaa ppp23 replied to the topic "What are some ways Document Control can improve?" - https://medicaldevicecourses.com/activity/p/13282/ Wed, 15 May 2019 17:03:35 -0400 Hi Hruship101, Read the below information: How You Determine Whether a Document Requires Quality Document Control Measures Companies should not view quality document control mandates, such as ISO 9001, as a curse. In truth, they can be blessings in disguise….   Read more»

]]> fa4856cada3fc1b187cde7a591e43977 ppp23 replied to the topic "Experience in Quality Assurance and Quality Control" - https://medicaldevicecourses.com/activity/p/13281/ Wed, 15 May 2019 17:03:34 -0400 Hi, I had to control the QA and QC of our production unit. The QC had to perform following checks for each batch of blend that is being prepared. 1. After cleaning of Blender, perform cleaning test visually, enter the…   Read more»

]]> fe9d43a2b7735bd2e8da922d020f7ae4 ppp23 replied to the topic "FDA on Recalled Items" - https://medicaldevicecourses.com/activity/p/13201/ Wed, 15 May 2019 17:02:51 -0400 Hi Everyone, The response to the question has been answered by many participants in this group. Most of them agree that FDA has initiated a recall for safety regulations. While researching over the internet, I found that US, UK and…   Read more»

]]> 0ac6421b33867ae7453730c7f0c42dfc ppp23 replied to the topic "Drugs banned in US but not in other countries" - https://medicaldevicecourses.com/activity/p/13171/ Wed, 15 May 2019 17:02:35 -0400 Hi Rd389

]]> 7a57705a834b60dcae9f0daca80948a1 ppp23 replied to the topic "Drugs banned in US but not in other countries" - https://medicaldevicecourses.com/activity/p/13170/ Wed, 15 May 2019 17:02:34 -0400 Hi Rd389

I found this link https://prescriptiondrugs.procon.org/view.resource.php?resourceID=005528 which tells about the drugs that are banned by FDA in US.

]]> cf7a920945ea8978d6b5208b0a7812d8 ppp23 replied to the topic "Drugs banned in US but not in other countries" - https://medicaldevicecourses.com/activity/p/13169/ Wed, 15 May 2019 17:02:34 -0400 Hi Rd389

There are many drugs that are currently banned in US and safe in other countries.
I found a weblink that tells about 35 drugs that are recalled and not considered safe in US although they were approved by FDA initially.

https://prescriptiondrugs.procon.org/view.resource.php?resourceID=005528

]]> 3dc235b81c08eb0211867e77cc3f4258 ppp23 replied to the topic "Precision and Accuracy" - https://medicaldevicecourses.com/activity/p/13168/ Wed, 15 May 2019 17:02:34 -0400 Hello All, While searching for the accuracy and precision over the internet, I came across a very interesting blog : Check the following link where people discuss about accuracy, reliability safety and regulations from other countries.They have explained multiple examples…   Read more»

]]> c0b0dffdc5903814bb617a60b80648ad ppp23 replied to the topic "Failure's of Pre-Clinical / Clinical Research" - https://medicaldevicecourses.com/activity/p/13011/ Wed, 15 May 2019 17:01:13 -0400 I have few questions for @rd389. 1. Why was a need to overdose animals? 2. What measures were taken to avoid future overdosing to animals? 3. How were the dead animals disposed? 4. Any care was taken during disposing, considering…   Read more»

]]> b7ae7d4d00959a6ff8c5c728bc150318 ppp23 replied to the topic "Ethics of Animal Testing" - https://medicaldevicecourses.com/activity/p/13010/ Wed, 15 May 2019 17:01:13 -0400 Numerous medical research foundations make utilization of non-human animals as guineas pigs. Animals might be liable to experimentation or changed into conditions valuable for picking up learning about human sickness or for testing potential human medicines. Since animals as inaccessible…   Read more»

]]> 7eb9071898809ccee2c53952b84c5e8d ppp23 replied to the topic "Research for the Fututre or Now?" - https://medicaldevicecourses.com/activity/p/12980/ Wed, 15 May 2019 17:00:58 -0400 i prefer working in industry and making products not only for current generation but for next generations too. Industry is very competitive whereas academia is not. Industry research is fast paced, target oriented and most importantly time. Academia research relates…   Read more»

]]> 08c5a15346efc524f6f28a3c338e3445 ppp23 replied to the topic "Project Manager Experiences" - https://medicaldevicecourses.com/activity/p/12832/ Wed, 15 May 2019 16:59:30 -0400 Hello Dbonanno1, Being a manger for two departments, it is difficult for managers as well to work with individuals with different personalities. I need to identify the level of each individual and assign them a position, just like a pyramid….   Read more»

]]> 6204167cf2fb5c46decff610b39d85d5 ppp23 replied to the topic "Multiple Project Managers for one project" - https://medicaldevicecourses.com/activity/p/12831/ Wed, 15 May 2019 16:59:30 -0400 In my opinion, multiple project managers for a single project is not an ideal solution. Multiple managers would involve multiple behaviors, acceptance on a single solution for a part of project is difficult, bringing all the managers to accept a…   Read more»

]]> 949d7ba3431a0b2aa22e24413d75c127 ppp23 replied to the topic "Milestones Missed: Failure or Success?" - https://medicaldevicecourses.com/activity/p/12830/ Wed, 15 May 2019 16:59:29 -0400 Hello Hruship101, This is a very good question. I would like to share my opinion over this. Missing a milestone is a failure of a project and it could be avoided by evaluating the overall/part of project. Utilizing a progression…   Read more»

]]> 56592c73f80eb21eac8e1088b50c1417 ppp23 replied to the topic "Advice for Biomedical Engineering Students" - https://medicaldevicecourses.com/activity/p/12787/ Wed, 15 May 2019 16:59:09 -0400 Contacts, Contacts and Contacts. They will get you jobs easily. Visit job expos in multiple cities, talk to people what you wish to do, apply for internships/co-ops, follow up with your application until a decision is made, emphasize more on…   Read more»

]]> 5894228e384b337b0348217efa37de4b ppp23 replied to the topic "Professions in Academia and the Industry" - https://medicaldevicecourses.com/activity/p/12786/ Wed, 15 May 2019 16:59:08 -0400 Hello kak33, I have been working as a Production and Purchasing Manager in Health Concepts since 3 years. We initially used to buy vitamins, supplements, proteins and health products from distributors and sell them on Amazon. The profit margins being…   Read more»

]]> bec9fc0b75138ccd4fe319230c4589b3 ppp23 replied to the topic "Discussion Topic: Academia vs. Industry" - https://medicaldevicecourses.com/activity/p/12785/ Wed, 15 May 2019 16:59:08 -0400 Benefits of working in Academia are completely different that industry. I would argue that while working in academia one has to be research oriented, keep on learning everyday, search for new ideas, work with students, freedom of deciding on work…   Read more»

]]> 563e43b6da294f043ebe6b4c6692ee35 ppp23 replied to the topic "Discussion Topic: Practical vs. Informational courses" - https://medicaldevicecourses.com/activity/p/12759/ Wed, 15 May 2019 16:58:55 -0400 I believe the ratio of 7:3 is perfect. One needs to have more academic knowledge as compared to practical knowledge. Experience teaches a lot. I strongly recommend knowledge over experience. Lets have an example: comparison between a person without knowledge…   Read more»

]]> b9937601b4f6a1639e5b6c6cb8e39b4c ppp23 replied to the topic Recent Examples of Kickback Allegations in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/5467/ Sun, 03 Dec 2017 17:15:01 -0500 As announced on Monday, October 17, 2016, by the United States Department of Justice (“DOJ”), the nation’s largest nursing home pharmacy, Omnicare Inc. (a CVS Health company), has agreed to pay $28.125 million to resolve allegations that it solicited and received kickbacks from pharmaceutical manufacturer Abbott Laboratories in exchange for promo…[Read more]

]]> 0 a76acc2ba4012821b6ec6c570d7dcd1b ppp23 replied to the topic NDA vs Patents in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/5409/ Wed, 29 Nov 2017 00:25:58 -0500 NDAs offer a standout amongst the most surefire approaches to protect trade secrets and other private data intended to be kept under wraps. Data normally protected by NDAs may incorporate schematics for another item, customer data, deals and promoting plans, or a novel assembling process. Utilizing a nondisclosure assention implies your secrets…[Read more]

]]> 0 511805b22795f7e11a298fb2f2c8ade8 ppp23 replied to the topic Discussion Topic: Course conclusion and impressions in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/5408/ Wed, 29 Nov 2017 00:01:27 -0500 Dr Simon,

I have learned a lot from this course. It gave me knowledge about the Regulatory affairs, Quality Control and Quality Assurance. It has helped me put the knowledge at work and I have been using your presentations to learn more about implementing at my work place.
Not to forget the midterm paper proposal, it has made me aware of…[Read more]

]]> 0 a52e319025cff68a38679c0e761512d6 ppp23 replied to the topic Organization types of medical devices? in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/5358/ Mon, 27 Nov 2017 03:10:15 -0500 I would prefer to have a matrix organization because :

Assets are utilized effectively and can move around between projects as required. You can chip away at loads of various things, once in a while in parallel—despite the fact that this point can be contended as a disservice too. Groups and people can be extremely responsive. In the event that a…[Read more]

]]> 0 1c30d6446fc2b01fa3265fc5d1af5222 ppp23 replied to the topic Forming a Project Team in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/5306/ Sun, 26 Nov 2017 19:38:13 -0500 Forming a project team is not an easy job. I would recommend to avoid following mistakes:

Mistake #1: Not meeting with the whole team and setting goals upfront

“It’s important for the entire team to know roles and responsibilities and deliverables” right from the start, says Shami Ahuja, director of agile practice at technology consulting firm…[Read more]

]]> 0 a3a18c5b4bbe35c0449006e4fdab77ca ppp23 replied to the topic Discussion Topic: Your organizational type in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/5305/ Sun, 26 Nov 2017 19:34:04 -0500 I would like to work for matrix organization because matrix management is ideal for sharing talents and skills across departmental boundaries. One of the most common scenarios for matrix management is when a group of individuals from all different functions organizes under a project manager to create something new and unique.The ability to draw…[Read more]

]]> 0 67b73b18b4012cb7efd396abd1e0389f ppp23 replied to the topic Manage Risk in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/5236/ Mon, 20 Nov 2017 04:35:54 -0500 Responding to the various categories of risk

There are four basic responses available to businesses depending on the category a given risk is placed:

Accept the risk as a cost of doing business, and decide to retain and budget for the risk ( self-insuring the risk)
Retain and budget for the cost of the risk, but take steps to reduce or avoid…[Read more]

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