https://medicaldevicecourses.com/members/hm243/activity/ Activity feed for hm243. Fri, 24 Apr 2026 18:41:04 -0400 https://buddypress.org/?v= en-US 30 hourly 2 ca134f3a953a7ab1bdb0a49cc4b9cb93 https://medicaldevicecourses.com/activity/p/15993/ Wed, 15 May 2019 19:15:58 -0400 Clinical Research Organizations, or CROs, are very beneficial to companies to have certain responsibilities for creating products to be done. With CROs, companies save money as they do not have to worry about expenses for human resources or equipment. CROs…   Read more»

]]> 206bd6ac73ab88ae89ea8b59c0284c04 https://medicaldevicecourses.com/activity/p/15990/ Wed, 15 May 2019 19:15:56 -0400 Completing the simulations throughout the semester helped me learn a lot about working in the industry. Having to go through different rounds to determine the causing factor for an error or to update documents, gave a look into what happens…   Read more»

]]> 2da187cc069ac07c69d911fa64914e63 https://medicaldevicecourses.com/activity/p/15989/ Wed, 15 May 2019 19:15:56 -0400 When looking into different possible career paths to consider within the Biomedical Engineering field, I have looked in to Clinical Research. I feel that it might be a position I might consider to try out maybe once to see if…   Read more»

]]> 75ee9c67269f35d105fab8715ce1f5e6 https://medicaldevicecourses.com/activity/p/15828/ Wed, 15 May 2019 19:14:21 -0400 A major reason as to why a clinical study may be stopped would be due to a side effect that was not expected. If one of the participants in the study ends up having a side effect, especially one that…   Read more»

]]> 9dccbd9f86a5fbfd06226d7f1af1e51c https://medicaldevicecourses.com/activity/p/15827/ Wed, 15 May 2019 19:14:21 -0400 The costs should not be the major determining factor in determining the location as to where clinical trials are held. Organizations should be putting their main focus on as to which location is relevant to their study or would allow…   Read more»

]]> 82934ca1c309334c4e1ddba629b747cb https://medicaldevicecourses.com/activity/p/15826/ Wed, 15 May 2019 19:14:20 -0400 After taking both the MDD and AMDD courses, the topics that are taught and reviewed within these courses are very beneficial. The courses shine light on processes that have to be followed within the work area and what the different…   Read more»

]]> 905d9656762dcfc4c43300959a5b87c3 https://medicaldevicecourses.com/activity/p/15702/ Wed, 15 May 2019 19:13:01 -0400 Companies should not have a choice as whether they have GMP’s or no GMP’s. The GMP lays the foundation for the company with a set of regulations that it needs to follow. This will provide order or organization to how…   Read more»

]]> 85fa7160cb2d421cda48a73a8b7d49d1 https://medicaldevicecourses.com/activity/p/15700/ Wed, 15 May 2019 19:13:00 -0400 It is important that companies, no matter how small, should include GMP’s, Good Manufacturing Practices. With GMP’s, a set outline of regulations or requirements is put in place for the company. If there is a startup company that does not…   Read more»

]]> d9fee235387f34ce67001e8486197739 https://medicaldevicecourses.com/activity/p/15698/ Wed, 15 May 2019 19:12:59 -0400 CAPA, Corrective and Preventative Actions, works to fix and improve products based on information gathered. CAPA consists of analyzing information received and classifying any problems. Based on this, certain actions are completed in order to prevent the problem from occurring…   Read more»

]]> fbd69f0d4758968617b66d3a47cf36ec https://medicaldevicecourses.com/activity/p/15677/ Wed, 15 May 2019 19:12:48 -0400 An internal audit may find issues in the quality system that the major audit may not have found. However, it would seem that this might not be effective. With an internal audit, the audit is completed by the quality employee…   Read more»

]]> 455db707652fc308a54f743bc3faf77d https://medicaldevicecourses.com/activity/p/15676/ Wed, 15 May 2019 19:12:47 -0400 The GMP, or Good Manufacturing Practice, gives a general outline of the requirements set for the company. This includes the methods, facilities, and controls within the project. The methods that are done to complete the project should meet with these…   Read more»

]]> 2fe40af23bc7bc8542985e469c8185d4 https://medicaldevicecourses.com/activity/p/15670/ Wed, 15 May 2019 19:12:44 -0400 As previous posts have stated, the decision depends mainly at the situation at the time and the company’s policies. Depending on the stage that the project is at, the project can either be grandfathered with the previous system or if…   Read more»

]]> be85c3c2713ac95c4203bbdfad48e816 https://medicaldevicecourses.com/activity/p/15587/ Wed, 15 May 2019 19:07:58 -0400 An essential phase within the product life cycle is the product introduction phase. In this stage, the transition from development to launch takes place. As the product enters the market, it is important to consider the current market value and…   Read more»

]]> fcff1d7544dad73c09c49971bb7f51d9 https://medicaldevicecourses.com/activity/p/15586/ Wed, 15 May 2019 19:07:57 -0400 Obsolescence of a product is important and plays a major role when product is no longer as popular or successful anymore. The company is wasting their resources and time creating more of these products, when they are not selling at…   Read more»

]]> 76d6ebee777e44e419781d709b1c6aff https://medicaldevicecourses.com/activity/p/15584/ Wed, 15 May 2019 19:07:56 -0400 When a company makes a deal with the customer, it is very important that the person making the deal has both interpersonal skills and business knowledge. Business knowledge is a key factor in making a business deal. If the team…   Read more»

]]> 687cfa1c51954ad69f68f931f0624bcd https://medicaldevicecourses.com/activity/p/15523/ Wed, 15 May 2019 19:07:16 -0400 Of all the phases involved in the product life cycle, as others have stated, the planning and development stage would seem to be the most expensive. During this stage in the product life cycle, the company is constantly working to…   Read more»

]]> 6a1699c2af7dddf7d7d36dfb033d746d https://medicaldevicecourses.com/activity/p/15516/ Wed, 15 May 2019 19:07:12 -0400 This is a very interesting topic to bring up. If the market does not seem appealing or in bad condition, then it would make sense for the company to decide to stop production. However, this could also, hurt them as…   Read more»

]]> ca0c0bc4db1568e4598d642124bfdfa5 https://medicaldevicecourses.com/activity/p/15481/ Wed, 15 May 2019 19:06:48 -0400 The product manager is in charge of a specific product being released and follows through the product’s life cycle. The product manager is in charge of making sure the product is successfully built and launched into the market. As others…   Read more»

]]> efe042789710c40a2cb6024a85f07251 https://medicaldevicecourses.com/activity/p/15292/ Wed, 15 May 2019 19:04:55 -0400 This is a very interesting factor to point out. Validation deals more with the process of ensuring that the customer’s needs are met. Verification focuses on making sure that the parts involved in creating the product are correct. The validation…   Read more»

]]> 4348d7e382a261b4b0028d14addd2b4b https://medicaldevicecourses.com/activity/p/15277/ Wed, 15 May 2019 19:04:44 -0400 In a situation like this, it is primarily important to determine the factor that caused the failure. Once the reason for failure is found, then measures can be taken to fix the issue and possibly prevent the failure from occurring…   Read more»

]]> 943bb4e7248c854ce01ef99634c09dcc https://medicaldevicecourses.com/activity/p/15275/ Wed, 15 May 2019 19:04:43 -0400 Although I haven’t dealt with a validation process in a work place, the process is very important in determining the effectiveness of the product. There are different types of validation methods; one type being retrospective validation. Retrospective validation is used…   Read more»

]]> a15f97b84343557c7bad7f18d7c210c5 https://medicaldevicecourses.com/activity/p/15220/ Wed, 15 May 2019 19:04:05 -0400 It is good to be proactive and reactive for medical devices. Medical devices may sometimes be used externally, but other times they will be implanted. From a business standpoint it would be more beneficial for a company to be proactive…   Read more»

]]> d6e9fd91e18d856d25589ffc0a334194 https://medicaldevicecourses.com/activity/p/15212/ Wed, 15 May 2019 19:04:01 -0400 It would seem a bit tedious to revalidate the equipment each time it is moved to a different location. However, it would be more beneficial to revalidate the equipment every time. Although the new location may reflect the same environment…   Read more»

]]> 05453c6465991e831a94d7b47bb6814b https://medicaldevicecourses.com/activity/p/15149/ Wed, 15 May 2019 19:03:27 -0400 This is a very interesting point to bring up. As others have mentioned, revalidation is necessary when the product or device has been modified or updated from the original design. However, if there are no changes and the device is…   Read more»

]]> ca4f15b4dec9884caf5505a3ee492149 https://medicaldevicecourses.com/activity/p/15059/ Wed, 15 May 2019 19:02:40 -0400 The SOP documents are important in the process of Design Transfer in ensuring the device will be able to be created following a routine. All parts of the SOP play a significant role in the document. I agree with you…   Read more»

]]> 7140f384a5a96648e153df95f02dbf69 https://medicaldevicecourses.com/activity/p/15056/ Wed, 15 May 2019 19:02:39 -0400 When starting a medical device company, it is very important that the validation processes for the devices are followed. As others have mentioned, it is key that the validation processes guarantee that the needs of the customer are met. There…   Read more»

]]> 69bf6e2eed5e67f381f8c19aa3435d14 https://medicaldevicecourses.com/activity/p/15050/ Wed, 15 May 2019 19:02:35 -0400 It does seem a bit tedious to repeatedly update the document when a new revision is made because then multiple documents will have to be updated as well. However, I do feel that it is very important and necessary that…   Read more»

]]> 6f1036ff58bf3317810abb18c49ecc28 https://medicaldevicecourses.com/activity/p/14930/ Wed, 15 May 2019 19:01:28 -0400 Both types of QMS are beneficial for a company to ensure the best quality products and work environment. The first type of QMS takes into consideration the general quality measure by including a quality manual, quality procedures, and records. The…   Read more»

]]> e904338da08c9bac65a018c1dd15353d https://medicaldevicecourses.com/activity/p/14927/ Wed, 15 May 2019 19:01:26 -0400 A written SOP can never be made to be too detailed. The SOP is written as a descriptive document containing instructions on how to create a specific product. The more details written in the document, the better off the product…   Read more»

]]> 52a3862520fa1eeb5ea2b86baf80df5c https://medicaldevicecourses.com/activity/p/14926/ Wed, 15 May 2019 19:01:26 -0400 The Standard Operating Procedures (SOP) is a very important document that is needed in describing the procedures needed to complete the making of a product and the steps involved. With the SOP, a set method is placed within to the…   Read more»

]]> 88a24431b4e804e8fa2753d2bf73acc2 https://medicaldevicecourses.com/activity/p/14800/ Wed, 15 May 2019 19:00:11 -0400 Of the two processes involved in the logging of changes made to the DHF, the second one seems better. When changes are being made to the product, even after the Design transfer, there should be a copy in the DHF…   Read more»

]]> fd64c01ba0ab8ee354fbdc2fe8267a2d https://medicaldevicecourses.com/activity/p/14798/ Wed, 15 May 2019 19:00:09 -0400 When comparing both types of documents, the DHF document would seem more useful than the Tech File / Design Dossier. The DHF file gives an overall informative description of the product. The Tech File / Design Dossier document just gives…   Read more»

]]> 4529e385a407fb6ab1630e23a230cc51 https://medicaldevicecourses.com/activity/p/14796/ Wed, 15 May 2019 19:00:08 -0400 The Validation or Verification test report is very significant in determining the success of a product. Once the Validation or Verification fails, it is important to go through the protocol step by step to find the factor that caused the…   Read more»

]]> 5447c6caa09409c816960301c5885c67 https://medicaldevicecourses.com/activity/p/14698/ Wed, 15 May 2019 18:59:17 -0400 In the US, the approvals for medical devices are done by the FDA. The FDA approves the device for the whole country, and has the ability to inspect and audit. In addition, they have the authority to take products off…   Read more»

]]> 3992edb8327d8e676dbc9ca892e94d30 https://medicaldevicecourses.com/activity/p/14697/ Wed, 15 May 2019 18:59:17 -0400 The classification of a device is determined by the risk of the device. If the device in question for classification has a higher risk, it is likely to have a higher classification. However, many device classifications differ between the EU…   Read more»

]]> 6e941ae178583697e50003abd19db8a1 https://medicaldevicecourses.com/activity/p/14694/ Wed, 15 May 2019 18:59:15 -0400 All three documents are important in their own way in ensuring the safety of medical devices. As a result of the MEDDEV Guidance Documents and Competent Authority Guidance Documents being written by the Competent Authorities, they do not have the…   Read more»

]]> 572d2f3334fb92895529df46e2f17a39 https://medicaldevicecourses.com/activity/p/14537/ Wed, 15 May 2019 18:57:47 -0400 I have not had any experience in defining the Primary Mode of Action (PMOA) for a combination device. The best way to define the device is by analyzing the two components involved in the product. Based on this, it will…   Read more»

]]> 0b35a19f3a1acc5baa1107b503f4fc1f https://medicaldevicecourses.com/activity/p/14533/ Wed, 15 May 2019 18:57:44 -0400 There are many factors to consider when using the multi-center form of clinical study. With this type of study, there could be variations between populations in their genetic makeup, cultural backgrounds, and environmental settings. This could affect comparison of results…   Read more»

]]> 0c19a723e087f3a5a61f8786d3f9b87b https://medicaldevicecourses.com/activity/p/14529/ Wed, 15 May 2019 18:57:41 -0400 The fifth P of marketing, participation plays a very important role in making an effective marketing strategy. With participation, the company promotes a stronger interaction between the employees and customers. As mentioned in the lecture, participation gives the customer control….   Read more»

]]> d443042598421f8d22c831b828d7fe81 https://medicaldevicecourses.com/activity/p/14406/ Wed, 15 May 2019 18:55:50 -0400 It is important that there is a restriction placed on the amount a company put into giving a gift to a physician. If there is no limit set on the amount of money a gift can be then it is…   Read more»

]]> 5242dcdace96e4671401c80c0a57e06b https://medicaldevicecourses.com/activity/p/14401/ Wed, 15 May 2019 18:55:47 -0400 The consultant does violate the NDA or CDA by copying the template from the previous company. Each company should follow their own template when completing contracts. Although companies are similar in their products and goals, that still doesn’t mean that…   Read more»

]]> 5d0f3d329bd3b251fc32745291e2f241 https://medicaldevicecourses.com/activity/p/14399/ Wed, 15 May 2019 18:55:46 -0400 When signing an NDA there are many factors to consider before accepting the contract. As mentioned above, it is very important to pay attention to what is written in the agreement and the time period for which it stands. Another…   Read more»

]]> eb0eb32ad120f636c7318bc1b874a62e https://medicaldevicecourses.com/activity/p/14242/ Wed, 15 May 2019 18:54:22 -0400 When determining which organizational structure is best for a company, it is important to take the company’s size into consideration. The organizational structure essentially determines the communication between the departments, which will determine the success of a project. Of the…   Read more»

]]> a2cdb7ea368dd30d227cea9cd02e46ad https://medicaldevicecourses.com/activity/p/14241/ Wed, 15 May 2019 18:54:21 -0400 It is healthy to have a little competition within a company, especially when it is friendly competition. However, if it becomes more than that, it can result in hurting the company’s work and its success. When there is negative competition…   Read more»

]]> 7eb01ae94f5d03f9f31d5053427e1548 https://medicaldevicecourses.com/activity/p/14240/ Wed, 15 May 2019 18:54:21 -0400 When two or more companies come together and decide on collaborating on a project, it is very important that the project is ran smoothly. There are issues that arise within a company when working on a project let alone collaborating…   Read more»

]]> cab003dc927b9515e1d658882a94d03f https://medicaldevicecourses.com/activity/p/14147/ Wed, 15 May 2019 18:52:29 -0400 The regulations are highly important in ensuring that the product follows the correct standards and is safe to use in the medical device market. It does seem a little unfair that the company has to pay for the regulations, but…   Read more»

]]> ab2f69250e70412f5919ed12891cb80c https://medicaldevicecourses.com/activity/p/14143/ Wed, 15 May 2019 18:52:26 -0400 Project Risk Management works to manage the possible risks a project may have and how to fix it. With Project Risk Management, projects are planned to have fewer risks. With Risk Identification, the risks that could affect the project are…   Read more»

]]> 6b7fe66aa9f61a7a82471ca4e3dda75c https://medicaldevicecourses.com/activity/p/14103/ Wed, 15 May 2019 18:51:56 -0400 As stated previously, the risk-benefit analysis is an important, when determining the benefits and risks that need to be considered for a product. One of the factors that is considered in the analysis is postmarket data. When the product is…   Read more»

]]> 19dc9f167377e8ded53ff2336eeb9aef https://medicaldevicecourses.com/activity/p/14013/ Wed, 15 May 2019 17:10:25 -0400 Validation is always an important step in the Design Controls. However, it is not necessarily always needed if there are no changes like you mentioned. Although that might be the case, I feel that a human factors evaluation should still…   Read more»

]]> 6637a6f2068a1a8e7178cf80cadd8f37 https://medicaldevicecourses.com/activity/p/14011/ Wed, 15 May 2019 17:10:24 -0400 Syringes are commonly used in medical care, such as for intravenous injection in hospitals. Syringes need to be tested and verified before even being used. Some of the tests used to determine the performance of the injector include ANSI, AAMI,…   Read more»

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