https://medicaldevicecourses.com/members/ao242/activity/ Activity feed for ao242. Sat, 25 Apr 2026 01:28:35 -0400 https://buddypress.org/?v= en-US 30 hourly 2 d4f58547007d76ae57e1186f5d6fba3d https://medicaldevicecourses.com/activity/p/14452/ Wed, 15 May 2019 18:57:06 -0400 I have sign a non compete agreement before and did not affected me from getting another job that I want. To my knowledge, non compete agreement is an agreement not to enter into or start a similar company or go…   Read more»

]]> 97faf2a762069c080525c9c3cb2bfcb6 https://medicaldevicecourses.com/activity/p/14446/ Wed, 15 May 2019 18:57:03 -0400 Oral agreement is as good as verbal agreement. A significant difference between oral and written contracts is that the time to sue for breach of an oral contract (the statute of limitations) is sometimes shorter.An oral contract is often provable…   Read more»

]]> f68d844f79d3b6a01718296155842863 https://medicaldevicecourses.com/activity/p/14445/ Wed, 15 May 2019 18:57:02 -0400 I enjoy the course and learn a lot. Although, I have some experience in medical device industry but this class has expand my knowledge and have me thinking of other profession in the field in can go in. The lectures…   Read more»

]]> 2fbb75161d9f18379b443010f962c5ba https://medicaldevicecourses.com/activity/p/14315/ Wed, 15 May 2019 18:55:03 -0400 I would would like to work in Matrix Organization because of its flexibility to drawing employees from different functional disciplines for assignment to a team without removing them from their respective positions. It is good in terms of large and…   Read more»

]]> b8208867fd0f55c44bd5bcd8a9660d98 https://medicaldevicecourses.com/activity/p/14314/ Wed, 15 May 2019 18:55:02 -0400 I would choose Matrix Organization for a startup medical device company that will function worldwide because of its flexibility to drawing employees from different functional disciplines for assignment to a team without removing them from their respective positions. It is…   Read more»

]]> f952b295e8fc448625eb9934359a2402 https://medicaldevicecourses.com/activity/p/14313/ Wed, 15 May 2019 18:55:02 -0400 Middle management is lower in position to Upper management. As briefly discussed in class and mentioned by you, the upper management are responsible for making the primary and strategic decisions within a company. This people are the CEO, CFO, CMO,…   Read more»

]]> afa97b289d67c0714487997a0b38d486 https://medicaldevicecourses.com/activity/p/14310/ Wed, 15 May 2019 18:55:00 -0400 Matrix Organization would be successful in collaboration projects in which two or more companies come together to develop and manufacture a product. Matrix approaches to projects and other initiatives are typically less expensive than establishing dedicated project teams, and the…   Read more»

]]> 157157dc7d4cf056428da46728370292 https://medicaldevicecourses.com/activity/p/14209/ Wed, 15 May 2019 18:53:03 -0400 One of the factors of Risk-benefit analysis according to FDA provided guidance is Patient Preference. It explains the importance of knowing any available patient preference information. Also to consider the modality of treatment/diagnostic procedure and the risk tolerance. FDA would…   Read more»

]]> 7f82e5f4eeb6395e0bb49821e96da8be https://medicaldevicecourses.com/activity/p/14208/ Wed, 15 May 2019 18:53:02 -0400 Risk management meeting should be ran by sharing the complied list of risks from previous project, if any in order to identify some common risks but also as a catalyst to get the participants thinking about risks. Identify duplicate risks…   Read more»

]]> 9b8f2ce74d374cc5bbaa9d669269dab2 https://medicaldevicecourses.com/activity/p/14207/ Wed, 15 May 2019 18:53:02 -0400 Labeling, instructions and warnings are required for medical devices. But least effective at preventing hazardous situations and foreseeable misuse. Another way to ensure proper use by the customer for their own safety is that the company should make sure the…   Read more»

]]> 4f0a66d54ab68da436b99e13490e7652 https://medicaldevicecourses.com/activity/p/14023/ Wed, 15 May 2019 17:10:30 -0400 I agree Communication management plan is important but thinks quality management plan is equally as important. Quality management plan monitor and verify that project deliverables meet defined quality standards. Quality assurance activities monitor and verify that the processes used to…   Read more»

]]> d166c95e7267f9b9f142a7178e7701e8 https://medicaldevicecourses.com/activity/p/14022/ Wed, 15 May 2019 17:10:30 -0400 To add to what has already been said, Verification makes sure that you have objective evidence that user needs and intended uses are met. With a mindset to “break the system” thereby identifying any defects and functions that could result…   Read more»

]]> 4545d0b26d04f86fb124d82e6199519c https://medicaldevicecourses.com/activity/p/14021/ Wed, 15 May 2019 17:10:29 -0400 A successful validation process contributes significantly to assuring the medical device quality and proves that the product produced is fit for its intended use. Quality, safety, and efficacy are all built into the product. I believe from the design stage…   Read more»

]]> 81f03f071b3bdc73683489b69a3ae842 https://medicaldevicecourses.com/activity/p/13819/ Wed, 15 May 2019 17:08:30 -0400 A whole lot as been said but will like to add that Good meeting minutes help drive a plan of action for your leadership team and employees. Help in the structure and state ownership.

]]> e717e6e4c8fbba69398de14e04046f63 https://medicaldevicecourses.com/activity/p/13817/ Wed, 15 May 2019 17:08:29 -0400 FDA looks for the following: The quality system: Processes and procedures define and implement to describe how the company addresses medical device regulations. Design History File (DHF): Demonstration of Design Controls throughout the product development process is expected and required….   Read more»

]]> 232a9e792aaccc047a734bef7cf94ab4 https://medicaldevicecourses.com/activity/p/13816/ Wed, 15 May 2019 17:08:28 -0400 The regulation of Medical Devices across the world is varies a lot, ranging from comprehensive to none. Some countries have a developed structure for regulation of Medical Devices, while some are partially done and the rest are either in the…   Read more»

]]> 8e0b615f3e9f3c1eb383b463e150b81a https://medicaldevicecourses.com/activity/p/13764/ Wed, 15 May 2019 17:08:00 -0400 The double blind study is more important in a clinical trial because it prevents the researcher from influencing the outcome of the experiment. Double-blind studies improve on experiments that compare the response of people taking a drug (or other treatment)…   Read more»

]]> bfc1fba25edf72751f843d3bd73d248b https://medicaldevicecourses.com/activity/p/13665/ Wed, 15 May 2019 17:07:04 -0400 I will like to play the role of a Biostatician. To be able to involve in clinical research trial design, protocol development, data management, monitoring for safety and efficacy, data analysis and observational studies reporting.

]]> 4f01728388b5ee5634475871833fa715 https://medicaldevicecourses.com/activity/p/13664/ Wed, 15 May 2019 17:07:03 -0400 Advantages of clinical studies includes the following: access to new treatments that work, improvement of future treatments and medical knowledge and discovery of fewer side effects compared to the standard treatment. Disadvantages of clinical studies includes; new discover treatment may…   Read more»

]]> 0daaa402607eb01642aa7191638ad305 https://medicaldevicecourses.com/activity/p/13663/ Wed, 15 May 2019 17:07:02 -0400 Clinical background is essential in clinical studies because majority of the roles you play has something to do with human life and in order to be successful in performing the task you need clinical knowledge. As stated in the question,…   Read more»

]]> 41d276875621ebac215381d0720792ef https://medicaldevicecourses.com/activity/p/13644/ Wed, 15 May 2019 17:06:51 -0400 The newly completed immunoassay and chemistry analyzer, Atellica Solution, designed to address common clinical laboratory challenges. It integrates immunoassay and clinical chemistry analyzers with the new standard in sample-management technology so you can focus on driving better outcomes. It was…   Read more»

]]> b08eda5fed4cba5319ac453ef008999d https://medicaldevicecourses.com/activity/p/13637/ Wed, 15 May 2019 17:06:47 -0400 Vision Statement: Describe the company values and purpose. Also emphasize on desire future of the company Mission Statement: Defines clearly how the company does business, Its goals and its approach to reach those objectives. Both Vision and Mission statement are…   Read more»

]]> cf482bc49f072f6852b3b4a66dad56d2 https://medicaldevicecourses.com/activity/p/13625/ Wed, 15 May 2019 17:06:40 -0400 A clever use of Participation will be through social media. Participation requires brand responses and engagement on at least the major social medias like facebook, twitter, instagram and snapchat. Adidas usage of theme/ hashtag and creative influencer campaigns on social…   Read more»

]]> de2eb7ee40e7c97358afd27ea84fe555 https://medicaldevicecourses.com/activity/p/13488/ Wed, 15 May 2019 17:05:19 -0400 Becton, Dickinson and Company Financial Report 2016 Revenues $ 12,483 Gross Profit Margin 48.0% Return on Revenues 7.8% Return on Total Assets(G) 5.6% Return on Equity 13.2% Debt to Capitalization(H) 57.2% Net Income 976 Operating Income 1,430 Dividends Per Common…   Read more»

]]> 0f28584c3ba763aa27949df5ee75566c https://medicaldevicecourses.com/activity/p/13478/ Wed, 15 May 2019 17:05:13 -0400 If I were to have ownership of a corporation, I would choose Corporation (S Corp. or C Corp.) Pros 1. Personal asset protection. 2.There is limited liability for business debts and obligations 3. Tax flexibility on personal income. Cons 1….   Read more»

]]> 1a7d332d5d60f8b8c12a80357d9ee6f1 https://medicaldevicecourses.com/activity/p/13474/ Wed, 15 May 2019 17:05:11 -0400 Public companies sold all or a portion of itself to the public. It’s Issues publicly traded stock and there is no limits to numbers of shareholder it could has. While, private companies are own by a small numbers of shareholders/…   Read more»

]]> ff8d5c314adf7b8da430eaa330054aa5 https://medicaldevicecourses.com/activity/p/13467/ Wed, 15 May 2019 17:05:08 -0400 The company will be better off to exist as an “Inc.” corporation than an “LLC”, first Corporation has limited liability, so the investors and owners are not generally liable for business debts and other liabilities. While an LLC, does has…   Read more»

]]> c7a55d753ee50fc26e179fb6c1dc4034 https://medicaldevicecourses.com/activity/p/13359/ Wed, 15 May 2019 17:04:16 -0400 I can see how quality is a burden if it’s not well executed, GxP for example which guides quality manufacture, testing, development and approval of drugs. These guidelines ensure that a product is safe and fulfills its intended use. If…   Read more»

]]> 52172fa884c93993e4613ddb11ca1c06 https://medicaldevicecourses.com/activity/p/13357/ Wed, 15 May 2019 17:04:15 -0400 To have a good quality control department the following should be done; A. Have a document management system in place. This will speed up documentation and no longer have to wait weeks for paper documents to make their way around…   Read more»

]]> 140557dbe20fcd8fd2df050d2ee2e42e https://medicaldevicecourses.com/activity/p/13353/ Wed, 15 May 2019 17:04:13 -0400 The ways to overcome such shortcoming and making sure procedures are also followed using R&D and Quality team as an example: first, the quality team must have appropriate product-specific technical expertise. They should have experienced in R&D field and contribute…   Read more»

]]> 8f2ef82088ffe50a6aff2b25a8adcef8 https://medicaldevicecourses.com/activity/p/13340/ Wed, 15 May 2019 17:04:07 -0400 Documentation control involves tracking document changes, revisions, and maintain of relevant versions company’s policies and procedures. This process takes significant amount of time when manaully done. The use of documentation management system would help reduce the lagging time for review…   Read more»

]]> 07a6b4fdebb150a1ebdfd7f72863b31c https://medicaldevicecourses.com/activity/p/13163/ Wed, 15 May 2019 17:02:31 -0400 What kind of regulatory pathway would be required for an antibiotic-releasing hip stem? CDRH Regulatory. Class 2 – Special Controls Is it a device, drug, biologic, or combination? Combination What is its “primary mode of action? Treatment of hip joint…   Read more»

]]> a4e8e0237523fb7a775576ba971984f4 https://medicaldevicecourses.com/activity/p/13162/ Wed, 15 May 2019 17:02:31 -0400 combination product: Vosevi. It is use for treatment of adults with chronic hepatitis C virus (HCV) genotypes 1–6 without cirrhosis or with mild cirrhosis. It’s department is under Biologics Regulation, CBER. And requires Premarket Approval Application (PMA). A CBER ->…   Read more»

]]> fc17598cefa68a8a68204e2529147fd6 https://medicaldevicecourses.com/activity/p/13161/ Wed, 15 May 2019 17:02:30 -0400 De Novo classification process involves new, novice unclassified devices using a risk based strategy to determine their class; class I, II or III. An application drafted by Medical Device Sponsor is sent to FDA to determine device type along with…   Read more»

]]> 5ad23cf5816c59b318e3d61e88a931b2 https://medicaldevicecourses.com/activity/p/13158/ Wed, 15 May 2019 17:02:29 -0400 FDA is not rigid instead they’re doing their best to protect public health by assuring the safety and efficacy of drugs. It will be devastating to its mission statement if a life-threatening product is approved and release to market. The…   Read more»

]]> 1628c49391dfb1de709221e60596e644 https://medicaldevicecourses.com/activity/p/13058/ Wed, 15 May 2019 17:01:36 -0400 It’s unethical but was the best method until recent when computer models are developed to simulate human biology. Animals like mice and rats share many physiological and genetic similarities with humans, animal experimentation can be tremendously helpful for furthering medical…   Read more»

]]> 866cf591e2c1ab0205c3ed94bce2e763 https://medicaldevicecourses.com/activity/p/12954/ Wed, 15 May 2019 17:00:42 -0400 Issues that would need to guard against when outsourcing an animal study to a university located about 1000 mi (1600 km) away from the company are as follow; Poor study design, time management, not enough money, communication and inappropriate bond…   Read more»

]]> 349a4ae1ae45e8a8f68840de80d6528d https://medicaldevicecourses.com/activity/p/12953/ Wed, 15 May 2019 17:00:41 -0400 An animal study is one of the most important steps in the process of translating biomaterials to clinical applications. But before going further to clinical trials, ISO 10993 standard will be ran to find out the initial biocompatibility of the…   Read more»

]]> 0c50a816b57e55ead57ebf3d7d3da520 https://medicaldevicecourses.com/activity/p/12932/ Wed, 15 May 2019 17:00:28 -0400 Industry projects are faster and tend to have higher rates of success due to large capital available for research and the quality level of experience team of engineers and scientists put together to work on the product. Also, not to…   Read more»

]]> 0e75635e99d22925bc78f375ba1dd313 https://medicaldevicecourses.com/activity/p/12915/ Wed, 15 May 2019 17:00:14 -0400 Working in the industry, not meeting project deadline happens all the time. As a product engineer in a reliability engineering department, obstacle faced was design failed to work and new design team was formed to redo project. Mechanical part of…   Read more»

]]> 5edc2bd2a56c65b7c948bf24d4997c77 https://medicaldevicecourses.com/activity/p/12914/ Wed, 15 May 2019 17:00:13 -0400 Which phase of the project life cycle do you think is crucial to the success of a project? Explain. Which phase of the project life cycle do you find least important? Explain. To answer your first question, i found initiating…   Read more»

]]> 2736a1751367f561eb2952ff413444da https://medicaldevicecourses.com/activity/p/12732/ Wed, 15 May 2019 16:58:41 -0400 Group of programs or projects are refer to Portfolio. The process used in execution of program or project is the strategy management. Portfolio management focus in identifying, prioritizing, and authorizing projects or programs. While in project management, one individual project…   Read more»

]]> 89a0088b6e0627f6fb9b573911c68d9e https://medicaldevicecourses.com/activity/p/12730/ Wed, 15 May 2019 16:58:36 -0400 A project manager for medical device will face the following challenges during the lifetime of the project; increase competition; other medical device companies are also working on similar product and with intent to attract new customers. Selling into global markets…   Read more»

]]> 3beebc6aca8202bc743c8bdb49131d90 https://medicaldevicecourses.com/activity/p/5504/ Mon, 04 Dec 2017 00:58:19 -0500 I have sign a non compete agreement before and did not affected me from getting another job that I want. To my knowledge, non compete agreement is an agreement not to enter into or start a similar company or go into competition against the company you’re currently working. The agreement usually lasted for about three to five years after one left…[Read more]

]]> 0 2f814c3bc691fb8282474590747dbe38 https://medicaldevicecourses.com/activity/p/5498/ Mon, 04 Dec 2017 00:46:11 -0500 Oral agreement is as good as verbal agreement. A significant difference between oral and written contracts is that the time to sue for breach of an oral contract (the statute of limitations) is sometimes shorter.An oral contract is often provable by action taken by one or both parties which is obviously in reliance on the existence of a contract.…[Read more]

]]> 0 93d9bebb99b2364369db5640ba4c07d3 https://medicaldevicecourses.com/activity/p/5497/ Mon, 04 Dec 2017 00:44:21 -0500 I enjoy the course and learn a lot. Although, I have some experience in medical device industry but this class has expand my knowledge and have me thinking of other profession in the field in can go in. The lectures are clear and very well explained. Discussion in forum is a very good idea, you get chance to express your thoughts on a particular…[Read more]

]]> 0 86e342d15d306b025686845f49f85428 https://medicaldevicecourses.com/activity/p/5357/ Mon, 27 Nov 2017 02:48:49 -0500 I would would like to work in Matrix Organization because of its flexibility to drawing employees from different functional disciplines for assignment to a team without removing them from their respective positions. It is good in terms of large and long time projects management. Employees in a matrix organization report on day-to-day performance…[Read more]

]]> 0 3dc53d899f7f205e647212d5011f9542 https://medicaldevicecourses.com/activity/p/5356/ Mon, 27 Nov 2017 02:42:29 -0500 I would choose Matrix Organization for a startup medical device company that will function worldwide because of its flexibility to drawing employees from different functional disciplines for assignment to a team without removing them from their respective positions. It is good in terms of large and long time projects management. Employees in a…[Read more]

]]> 0 b2486be63d1a240f96e3786fb737f036 https://medicaldevicecourses.com/activity/p/5354/ Mon, 27 Nov 2017 02:29:17 -0500 Middle management is lower in position to Upper management. As briefly discussed in class and mentioned by you, the upper management are responsible for making the primary and strategic decisions within a company. This people are the CEO, CFO, CMO, CSO ect. While Middle management are responsible for implementing the top management’s policies and…[Read more]

]]> 0 e4492ac08ee19c37f477f1807741dd04 https://medicaldevicecourses.com/activity/p/5351/ Mon, 27 Nov 2017 01:53:15 -0500 Matrix Organization would be successful in collaboration projects in which two or more companies come together to develop and manufacture a product. Matrix approaches to projects and other initiatives are typically less expensive than establishing dedicated project teams, and the diversity of the team members makes them superior to many purely…[Read more]

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