Medical Device Courses | ds654 | Activity https://medicaldevicecourses.com/members/ds654/activity/ Activity feed for ds654. Fri, 24 Apr 2026 20:47:02 -0400 https://buddypress.org/?v= en-US 30 hourly 2 6307b51c0bf31e0e236ffde09f4015ec ds654 replied to the topic "Alternatives dispute resolution" - https://medicaldevicecourses.com/activity/p/11436/ Wed, 15 May 2019 16:44:58 -0400 Alternative dispute resolution (ADR) refers to techniques used to resolve conflicts without going to the courtroom. As healthcare and malpractice costs continue to rise, there is growing interest in tactics such as early apology, mediation, and arbitration in the medical…   Read more»

]]> 01e9fc77ce6ab870ab90ffd6fc2bc0e3 ds654 replied to the topic "Recent Examples of Kickback Allegations" - https://medicaldevicecourses.com/activity/p/11434/ Wed, 15 May 2019 16:44:56 -0400 In January, the former owner and the former operator of a California durable medical equipment company were sentenced for paying physicians kickbacks for patient referrals and prescriptions for unnecessary equipment — primarily power wheelchairs — which were used to support…   Read more»

]]> 62fb84138705c7f27d58647f7e635969 ds654 replied to the topic "Anti-kickback & Stark Cases" - https://medicaldevicecourses.com/activity/p/11429/ Wed, 15 May 2019 16:44:53 -0400 The False Claims Act offers whistleblowers an effective way to expose and stop kickbacks in the healthcare system. Kickbacks – hidden financial arrangements between doctors and hospitals or other healthcare providers or companies – are one of the most complicated…   Read more»

]]> 4c0d1ba0781c1852939cc55b20830f84 ds654 replied to the topic "Organization Type vs. Effectiveness" - https://medicaldevicecourses.com/activity/p/11288/ Wed, 15 May 2019 16:43:38 -0400 A key element in organization (and work units within an organization) success is its structure – how its work activities are organized; and how responsibility and authority are identified. Structure affects how employees – even at the very top of…   Read more»

]]> f099ed8a6c7e6294c2594d361f066c61 ds654 replied to the topic "Organizational Behavior Management" - https://medicaldevicecourses.com/activity/p/11278/ Wed, 15 May 2019 16:43:33 -0400 The way employees behave at work will differ from their behavior as individuals in a social setting. A variety of factors influence organizational behavior, including the company’s structure, policies and procedures, management effectiveness and interactions between colleagues. All of these…   Read more»

]]> 0ea9ac78c7469b24512133a1514b652b ds654 replied to the topic "Organizational structure and Culture both leading to project success?" - https://medicaldevicecourses.com/activity/p/11276/ Wed, 15 May 2019 16:43:32 -0400 I agree there will be an impact of culture on organizational Structure. Organisations can change with time. What was once a very informal office atmosphere may have to become more formal as the size and scope of the business expands….   Read more»

]]> 73220f3ffab98b45a4492701077a1716 ds654 replied to the topic "Factors Contributing to Risk Values" - https://medicaldevicecourses.com/activity/p/11192/ Wed, 15 May 2019 16:40:51 -0400 Factor analysis of information risk (FAIR) is a taxonomy of the factors that contribute to risk and how they affect each other. FAIR underlines that risk is an uncertain event and one should not focus on what is possible, but…   Read more»

]]> 34dd6e7252c0f2ff2d5aadccb5e215a1 ds654 replied to the topic "Risk management methods" - https://medicaldevicecourses.com/activity/p/11190/ Wed, 15 May 2019 16:40:50 -0400 Risk Management Methods start with Risk Screening. Starting from categorizing them from High Impact and High probability, risks are analyzed using a number of methods. The PDRI(Project Definition Rating Index) is used in front-end project planning to help the project…   Read more»

]]> 78a2407da57abfbe4075b6f70d9c5711 ds654 replied to the topic "Risk Management - Identification" - https://medicaldevicecourses.com/activity/p/11188/ Wed, 15 May 2019 16:40:49 -0400 The risk identification process on a project is typically one of brainstorming, and the usual rules of brainstorming apply: 1.The full project team should be actively involved. 2.Potential risks should be identified by all members of the project team. 3.No…   Read more»

]]> c5b28a40987a642000c38128d96d4da9 ds654 replied to the topic "When is validation is not required?" - https://medicaldevicecourses.com/activity/p/11055/ Wed, 15 May 2019 16:39:29 -0400 According to the US Food and Drug Administration’s Quality System Regulation (Code of Federal Regulations Title 21 Part 820), 820.3(z) Validation means establishing by objective evidence that the particular requirements for a specific intended use can be consistently fulfilled and…   Read more»

]]> c34e3dc42c68718fe0592f57b72e050a ds654 replied to the topic "Combination Product Phase I clinical Studies" - https://medicaldevicecourses.com/activity/p/11053/ Wed, 15 May 2019 16:39:27 -0400 Design transfer is an integral process in the early life of a product. It must be well executed, especially for complex medical devices. FDA’s quality system regulation requires the manufacturer to complete the following steps in order to satisfactorily complete…   Read more»

]]> 7669f2ccd459b138391050b9d40712e1 ds654 replied to the topic "Customer Needs, Business Requirements, Test Plan" - https://medicaldevicecourses.com/activity/p/11046/ Wed, 15 May 2019 16:39:23 -0400 I understand how frustrating sometimes it can be to refer to a small parameter in these test documents or the product documents. But, when a product is not functioning to it’s ability, one factor could one or more specifications listed…   Read more»

]]> 061d9521b776021bc8712b95fce09ae8 ds654 replied to the topic "Important Part of DDP" - https://medicaldevicecourses.com/activity/p/10923/ Wed, 15 May 2019 16:37:58 -0400 Design Development Plan is the foremost important aspect in starting a medical device project. According to FDA regulations on Design & Development Planning (820.30(b)), “Each manufacturer shall establish and maintain plans that describe or reference the design and development activities…   Read more»

]]> ec95218d129af818e02ffb237aa55e28 ds654 replied to the topic "Design input sources" - https://medicaldevicecourses.com/activity/p/10921/ Wed, 15 May 2019 16:37:57 -0400 Design Inputs make up of higher level requirements, that trace to Design Outputs which is a more low-level specific requirement. One way to maintain their inputs is the Design Input Document, that is maintained in the DHF, which Quality can…   Read more»

]]> 10f6efddcffa8ea92b70d41d7b789248 ds654 replied to the topic "Design Verification & Validation" - https://medicaldevicecourses.com/activity/p/10919/ Wed, 15 May 2019 16:37:56 -0400 Validation and verification are frequently mentioned in tandem. They’re often called V&V. To get a good understanding of this, I wanted to add a few points that would explain the difference a little better.The literal meaning of validation means “the…   Read more»

]]> 42e14e83fb116de1666a534742e4ef3f ds654 replied to the topic Alternatives dispute resolution in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/938/ Mon, 05 Dec 2016 04:44:52 -0500 Alternative dispute resolution (ADR) refers to techniques used to resolve conflicts without going to the courtroom. As healthcare and malpractice costs continue to rise, there is growing interest in tactics such as early apology, mediation, and arbitration in the medical arena. A major obstacle to more widespread use of ADR in the medical…[Read more]

]]> 0 6248119b56ea661a1de5ad5462380a16 ds654 replied to the topic Recent Examples of Kickback Allegations in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/935/ Mon, 05 Dec 2016 04:36:58 -0500 In January, the former owner and the former operator of a California durable medical equipment company were sentenced for paying physicians kickbacks for patient referrals and prescriptions for unnecessary equipment — primarily power wheelchairs — which were used to support fraudulent Medicare claims.

The following is the link to the Art…[Read more]

]]> 0 cb49a0cd299a6955ecbc2962d18de737 ds654 replied to the topic Anti-kickback & Stark Cases in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/930/ Mon, 05 Dec 2016 04:26:29 -0500 The False Claims Act offers whistleblowers an effective way to expose and stop kickbacks in the healthcare system. Kickbacks – hidden financial arrangements between doctors and hospitals or other healthcare providers or companies – are one of the most complicated and troubling aspects of the healthcare system.

Kickbacks to doctors or other hea…[Read more]

]]> 0 6f16e91b24ce257e6eda42d9755aa1af ds654 replied to the topic Organization Type vs. Effectiveness in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/759/ Mon, 28 Nov 2016 00:45:47 -0500 A key element in organization (and work units within an organization) success is its structure – how its work activities are organized; and how responsibility and authority are identified. Structure affects how employees – even at the very top of the organization – execute their responsibilities and authority, coordinate and work with other…[Read more]

]]> 0 efe5cae189f5e8e8fd8254502a6d7539 ds654 replied to the topic Organizational Behavior Management in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/749/ Mon, 28 Nov 2016 00:04:12 -0500 The way employees behave at work will differ from their behavior as individuals in a social setting. A variety of factors influence organizational behavior, including the company’s structure, policies and procedures, management effectiveness and interactions between colleagues. All of these elements can inspire employees to work harder or…[Read more]

]]> 0 a79126c546787b089200ae6b428a79a6 ds654 replied to the topic Organizational structure and Culture both leading to project success? in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/747/ Sun, 27 Nov 2016 23:38:20 -0500 I agree there will be an impact of culture on organizational Structure. Organisations can change with time. What was once a very informal office atmosphere may have to become more formal as the size and scope of the business expands. Understanding organisational culture and structure helps decision-makers do the right thing. Those executives must…[Read more]

]]> 0 6d39625035336c0556daf599d9f3e7d6 ds654 replied to the topic Factors Contributing to Risk Values in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/638/ Mon, 21 Nov 2016 04:59:54 -0500 Factor analysis of information risk (FAIR) is a taxonomy of the factors that contribute to risk and how they affect each other. FAIR underlines that risk is an uncertain event and one should not focus on what is possible, but on how probable is a given event. This probabilistic approach is applied to every factor that is analysed. The risk is the…[Read more]

]]> 0 111de0f1a3e6a731bcf20aeb304be1b4 ds654 replied to the topic Risk management methods in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/636/ Mon, 21 Nov 2016 04:54:20 -0500 Risk Management Methods start with Risk Screening. Starting from categorizing them from High Impact and High probability, risks are analyzed using a number of methods.

The PDRI(Project Definition Rating Index) is used in front-end project planning to help the project team assess project scope definition, identify risk elements, and subsequently…[Read more]

]]> 0 493f244bbcad068faccf6e203b07d4ec ds654 replied to the topic Risk Management - Identification in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/634/ Mon, 21 Nov 2016 04:43:09 -0500 The risk identification process on a project is typically one of brainstorming, and the usual rules of brainstorming apply:
1.The full project team should be actively involved.
2.Potential risks should be identified by all members of the project team.
3.No criticism of any suggestion is permitted.
4.Any potential risk identified by anyone should…[Read more]

]]> 0 4468d9c40d755d190a83cc65e772a985 ds654 replied to the topic When is validation is not required? in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/459/ Mon, 14 Nov 2016 05:16:01 -0500 According to the US Food and Drug Administration’s Quality System Regulation (Code of Federal Regulations Title 21 Part 820), 820.3(z) Validation means establishing by objective evidence that the particular requirements for a specific intended use can be consistently fulfilled and 820.3(aa) Verification means confirmation by examination and p…[Read more]

]]> 0 6463971098a2bf5b5a20e667129d35cc ds654 replied to the topic Combination Product Phase I clinical Studies in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/457/ Mon, 14 Nov 2016 04:59:41 -0500 Design transfer is an integral process in the early life of a product. It must be well executed, especially for complex medical devices. FDA’s quality system regulation requires the manufacturer to complete the following steps in order to satisfactorily complete the design transfer process:
* ensuring the device design–configuration
* Transfer…[Read more]

]]> 0 c01db1aa30677c0396141090e759174a ds654 replied to the topic Customer Needs, Business Requirements, Test Plan in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/449/ Mon, 14 Nov 2016 04:44:56 -0500 I understand how frustrating sometimes it can be to refer to a small parameter in these test documents or the product documents. But, when a product is not functioning to it’s ability, one factor could one or more specifications listed could be a failure. Though tiring, it’s always preferred to go back and refer the document and then modify the…[Read more]

]]> 0 a67d017604c91622d2bfa398c823a72a ds654 replied to the topic Important Part of DDP in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/282/ Mon, 07 Nov 2016 04:57:18 -0500 Design Development Plan is the foremost important aspect in starting a medical device project. According to FDA regulations on Design & Development Planning (820.30(b)), “Each manufacturer shall establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation. The plans…[Read more]

]]> 0 22e048649ef2e6b1aad8adff7190544d ds654 replied to the topic Design input sources in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/280/ Mon, 07 Nov 2016 04:48:11 -0500 Design Inputs make up of higher level requirements, that trace to Design Outputs which is a more low-level specific requirement. One way to maintain their inputs is the Design Input Document, that is maintained in the DHF, which Quality can refer to.

However, I was wondering if those of you in a medical device company, maintain these Design…[Read more]

]]> 0 d3ab4e1e33f24fb2cc6db563df7310bd ds654 replied to the topic Design Verification & Validation in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/278/ Mon, 07 Nov 2016 04:34:58 -0500 Validation and verification are frequently mentioned in tandem. They’re often called V&V.

To get a good understanding of this, I wanted to add a few points that would explain the difference a little better.The literal meaning of validation means “the process of checking that something satisfies a certain criterion,”and verification can mean: “ad…[Read more]

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