https://medicaldevicecourses.com/members/at644/activity/ Activity feed for at644. Sat, 16 May 2026 09:07:01 -0400 https://buddypress.org/?v= en-US 30 hourly 2 6fa0c0a640e9d1a1c8171c138c118c2b https://medicaldevicecourses.com/activity/p/48644/ Sun, 03 May 2026 22:58:17 -0400 As others have mentioned, I have learned to value effective communication, especially from senior management, where it is more meaningful and important. I have found that something as simple as frequent communication, even if it is weekly or bi-weekly, and…   Read more»

]]> a074406a6e1102caaa10ca9c419229c9 https://medicaldevicecourses.com/activity/p/48544/ Sun, 03 May 2026 01:43:55 -0400 A bid process can be conducted to select the CRO for the clinical trial. The project manager can create and send a request for proposal to multiple CROs and evaluate them based on costs, experience, available resources, compliance history, and…   Read more»

]]> 95b3b7d3b1527e1c6de874c7470cca81 https://medicaldevicecourses.com/activity/p/48245/ Thu, 30 Apr 2026 02:04:12 -0400 Proper scope change control can mitigate some of the risks of scope creep by identifying changes and taking the steps to get them approved and managed. For the most part, project scope changes are viewed negatively because they require additional…   Read more»

]]> 790f52ab6b1270c610c1464919ddbd44 https://medicaldevicecourses.com/activity/p/47923/ Mon, 27 Apr 2026 00:55:02 -0400 Incorporating diverse sites in a clinical trial that are not the major academic hospitals, as you mentioned, would be one of the best ways to involve more groups of people. This would require greater leverage and outreach by trial members…   Read more»

]]> 28d8f5fca4e18edb591b67fcfcecd8b4 https://medicaldevicecourses.com/activity/p/47918/ Sun, 26 Apr 2026 23:41:59 -0400 An individual’s performance, which is also based on their knowledge and current skills, can greatly affect their goals and the paths available to achieve them. Someone with extensive project experience may be motivated by an exciting project because it gives…   Read more»

]]> f2a61688427ff3c1b54f49ab721304a9 https://medicaldevicecourses.com/activity/p/47708/ Sat, 25 Apr 2026 02:55:01 -0400 A communications plan is important in a clinical trial because the project manager will engage with project members and stakeholders at other sites or organizations, and regulatory bodies. For example, obtaining FDA and IRB approval for the clinical trial will…   Read more»

]]> 79a34d871b4ae126909388ef960ea638 https://medicaldevicecourses.com/activity/p/47204/ Sun, 19 Apr 2026 23:51:36 -0400 Project management starts in the early stages of a project, but work is also done before project approval is obtained. Before the scope is developed, a feasibility study can be conducted to determine the scope and support project initiation. The feasibility…   Read more»

]]> 8ba39fcda3198f2ea13f0e25f781f345 https://medicaldevicecourses.com/activity/p/47176/ Sun, 19 Apr 2026 20:55:36 -0400 Procurement processes in the medical device industry are significant due to strict regulatory requirements along with expected quality and safety standards. If a team is trying to find a new vendor, then the project manager may be working on costs…   Read more»

]]> ff1186a3d72efa402b4ef7a9edb4813b https://medicaldevicecourses.com/activity/p/47089/ Sun, 19 Apr 2026 03:58:18 -0400 Cost estimation tools can help grasp an unknown budget, and potential changes, such as new requirements or design changes, should be incorporated. Most importantly, having a well-defined project with detailed tasks will more accurately determine the required budget, rather than…   Read more»

]]> 252079b42d9779ee56b122090bc7e5b9 https://medicaldevicecourses.com/activity/p/46476/ Mon, 13 Apr 2026 00:59:20 -0400 When hiring, whether externally or internally, the PM should consider the project team’s size and the need for full-time or part-time availability. The project team’s location is also important, as there may be preferences for either external or internal hiring…   Read more»

]]> 100aefea97c362a4d4ea6b973f2d7c8e https://medicaldevicecourses.com/activity/p/46359/ Sun, 12 Apr 2026 02:19:08 -0400 The success of a medical device project depends on stakeholder involvement, among other factors, as their contributions to design, quality, and safety are valuable. Their industry experience and connections allow easier implementation when the product hits the market. However, when…   Read more»

]]> 029d40b33e7c76c9de8fac0aca4234bc https://medicaldevicecourses.com/activity/p/46170/ Fri, 10 Apr 2026 03:19:34 -0400 Clinical trials, usability testing, and software validation are common methods used in the medical device industry. For example, software validation can ensure the system does not crash and includes preventive measures when a user makes mistakes, which replicates a real-world…   Read more»

]]> c9b8a096164b3dbaa0c673a74c5138d0 https://medicaldevicecourses.com/activity/p/45139/ Mon, 30 Mar 2026 01:15:31 -0400 I have found that the size of the organization or project team has a significant impact on change fatigue. A smaller team struggles to keep up with frequent changes while other tasks remain to be completed. Likewise, rotating or new…   Read more»

]]> 889a6f4b315b70cffa2eef4bbbf1b2ba https://medicaldevicecourses.com/activity/p/45131/ Mon, 30 Mar 2026 00:11:18 -0400 Relying too heavily on metrics like EV, PV, and AC can hurt the team when they cannot control the variables that affect them. If the project scope is not defined, the tasks in the work breakdown structure are less accurate…   Read more»

]]> d8c80d9a61bb71010ae73d6bc6adeee3 https://medicaldevicecourses.com/activity/p/45041/ Sun, 29 Mar 2026 03:48:22 -0400 Incorporating review meetings throughout the project stages is highly recommended for monitoring, and auditors can request a review of the quality of this information. These meetings can be used to discuss or approve change drafts, or reveal changes that need…   Read more»

]]> 1daf7cfa5f454e9aeb0e8e7cfbf05911 https://medicaldevicecourses.com/activity/p/43802/ Sun, 15 Mar 2026 21:20:54 -0400 Estimation failures during the planning phase can threaten the project’s success, as the project is more likely to have a higher burn rate, increasing the risk of running out of budget before project milestones are completed. Actual resource costs are…   Read more»

]]> 1d5f4033fd32db1be4374c6e85b81caf https://medicaldevicecourses.com/activity/p/43729/ Sun, 15 Mar 2026 04:25:19 -0400 Performing project quality assurance or monitoring & controlling the project execution are significant for its success. Preventive actions, such as obtaining the proper document signatures and retraining staff, support the process improvement and the quality management plan. Reviewed and approved…   Read more»

]]> 856bad0a82cc6616e2d21920d935fac2 https://medicaldevicecourses.com/activity/p/43602/ Sat, 14 Mar 2026 00:42:39 -0400 Verification includes testing to determine if the inputs match the outputs. Validation, on the other hand, assesses whether the inputs meet the user’s needs and whether the device does what it’s supposed to do. For design validation, the product must…   Read more»

]]> ca9b0de99639947f7d3661dd8e57dc5a https://medicaldevicecourses.com/activity/p/43079/ Sun, 08 Mar 2026 21:07:05 -0400 Someone with a science degree can also become a project manager. If they have additional work experience, they can be attractive to a medical device organization, especially if they have product lines focused on biologics or combination products. I agree…   Read more»

]]> e9cff13b5c7e4d0db83551fb4997ab3b https://medicaldevicecourses.com/activity/p/43011/ Sun, 08 Mar 2026 04:02:44 -0400 Testing results should be communicated to stakeholders or senior management, and the project manager will need their approval to proceed with further action. Approaching a preliminary test includes identifying a clear purpose and, for many, choosing the testing solution that…   Read more»

]]> 97bac3e2bca0b4d5109708ed4a99b75e https://medicaldevicecourses.com/activity/p/42986/ Sat, 07 Mar 2026 22:38:50 -0500 Early-stage risk assessments are less expensive than addressing the risks as they arise. Taking risks should not come at the expense of safety, and their significance depends on their severity and probability. Realistically, certain risks may be accepted, but the…   Read more»

]]> 03dcbef9dde31812efabff946b7a2421 https://medicaldevicecourses.com/activity/p/42396/ Mon, 02 Mar 2026 01:12:30 -0500 Including costs and resources in the risk management analysis can lower project estimates. Finding alternatives to different resources to mitigate risk can increase project success. Having a vendor when internal production issues arise, or training additional employees for coverage, are…   Read more»

]]> 59aa5a32734db127a665d815c84c8c29 https://medicaldevicecourses.com/activity/p/42377/ Sun, 01 Mar 2026 22:29:34 -0500 I had a lab research project that followed a finish-to-start mode, where each task could not begin until the previous task was completed. A finish-to-start relationship is common, especially in the laboratory; for example, a sample cannot be analyzed until…   Read more»

]]> 54837ec1ad9de1bebf63b99516592ac3 https://medicaldevicecourses.com/activity/p/42176/ Sat, 28 Feb 2026 02:25:58 -0500 An organization running multiple projects will have many tasks that should ideally be organized, and there are different methods for planning them. Depending on the organization’s level of project management sophistication, the task breakdown can range from using pen and…   Read more»

]]> d7472638fbdd52dc2a076cabce093a60 https://medicaldevicecourses.com/activity/p/41559/ Sun, 22 Feb 2026 23:56:11 -0500 Poor execution and late regulatory integration are both common pitfalls for medical device developers. Startups are likely to design medical devices with a strong emphasis on innovation, and risk integrating regulatory compliance later than necessary. This can be an example…   Read more»

]]> a973ffeac48aed3f2e21f0b77df94bdf https://medicaldevicecourses.com/activity/p/41433/ Sun, 22 Feb 2026 02:25:37 -0500 Regulatory authorities, third-party organizations, or internal auditors will issue their findings, including identified non-compliances or non-conformances. Not having a written procedure is a failure to meet an internal requirement or an established standard. However, it does happen, and it is…   Read more»

]]> 42566dd1521f2f8c72415955292cc7fd https://medicaldevicecourses.com/activity/p/41287/ Fri, 20 Feb 2026 23:09:53 -0500 Fair treatment and engagement with team members are part of stewardship, which embodies a broader commitment to the organization and its stakeholders. Project managers should use lessons learned from previous projects to identify members’ strengths and weaknesses, including their behaviors….   Read more»

]]> 34ccc65d83dee6a1936f12557fbb92cc https://medicaldevicecourses.com/activity/p/40684/ Sun, 15 Feb 2026 23:07:05 -0500 Another regulatory strategy is the “De Novo” pathway for a 510(k), under which a low- or moderate-risk medical device that lacks a substantially equivalent predicate device can still be classified as a class I or class II device. This is…   Read more»

]]> 5dd1e73289d1a66fabd449d0afbe04f8 https://medicaldevicecourses.com/activity/p/40471/ Sat, 14 Feb 2026 02:39:25 -0500 Different organizational structures have both pros and cons. While these structures affect projects and their outcomes, they are also influenced by other organizational factors, as others have shared. Managers who are unsure about which projects and responsibilities are theirs, or…   Read more»

]]> 1adae97260b63377b39b72f702c58277 https://medicaldevicecourses.com/activity/p/40123/ Wed, 11 Feb 2026 02:28:51 -0500 Soft skills can be used to align business needs with customer satisfaction. Empathy and active listening help when dealing with customers, especially since the project manager is trying to maintain a stable relationship in every interaction. However, the project manager…   Read more»

]]> 5737c5f74b74450cbb1c4d877cc5f8dc https://medicaldevicecourses.com/activity/p/39866/ Sun, 08 Feb 2026 23:16:10 -0500 Users benefit from training in information systems, including software tools, which help them use it more effectively and efficiently. I do not have experience with Jira; however, the platform is popular for its usability and support. Further training may be…   Read more»

]]> 22825468b7f46fa7670ccbd8de7773a7 https://medicaldevicecourses.com/activity/p/39741/ Sat, 07 Feb 2026 23:14:42 -0500 The phases of the product life cycle can change in response to internal and external factors. Products such as smartphones become obsolete quickly, and newer models are released. Medical devices may also have short product lifecycles due to competition and…   Read more»

]]> 281b9220af092cba80951b1b36c39c92 https://medicaldevicecourses.com/activity/p/39655/ Sat, 07 Feb 2026 04:34:34 -0500 Project management varies across companies, reflecting differences in organizational behavior, value delivery systems, and infrastructure. Incorporating project management into design controls while maintaining distinctions, such as design risk vs. project risk, may not be fully implemented across the organization. Project management…   Read…[Read more]

]]> d5efbfcd688a00e0a49205d6c7acd9f5 https://medicaldevicecourses.com/activity/p/38600/ Sun, 01 Feb 2026 04:48:54 -0500 The company’s organizational structure can affect the project manager’s responsibilities. The project manager has more power than a functional manager in a strong matrix organization, which can give them control over post-market surveillance or projects related to regulatory or quality….   Read more»

]]> cbd92475ae4e8f052b2c806a03c7cb1a https://medicaldevicecourses.com/activity/p/38272/ Sat, 31 Jan 2026 04:02:26 -0500 A project manager can evaluate the project outcomes and monitor its products. Results of the project can be assessed for their benefits or value, especially as they continue to be used or produced in the post-market phase. Monitoring the products…   Read more»

]]> b24cd983c2d8676b94b5de98075e44a4 https://medicaldevicecourses.com/activity/p/37568/ Wed, 28 Jan 2026 04:49:03 -0500 A company may or may not pursue a pathway based on its capabilities or motives. Challenges can arise during the process of submitting a 510(k) or PMA. However, depending on the company, the project can be scrapped entirely because it…   Read more»

]]> f36b42337e4b2128ffdf9eeea41ef4d9 https://medicaldevicecourses.com/activity/p/36923/ Sun, 25 Jan 2026 22:35:52 -0500 A project manager who understands value will help them navigate the stakeholder expectations and stay within scope. Value delivery can improve the team and company environment, where the work produced is about quality and not primarily about quantity. Having a…   Read more»

]]> ed2e593e97ff9256839a0d093d135b80 https://medicaldevicecourses.com/activity/p/36671/ Sun, 25 Jan 2026 02:20:47 -0500 I agree with Jacob that regulatory or quality engineering are appropriate fields for a project manager to have experience in. Furthermore, a background in quality assurance greatly benefits a project manager. Understanding quality management systems (QMS) and how a company…   Read more»

]]> 7ee87c92e3b9c29cc3b13a2a5bfc1fa5 https://medicaldevicecourses.com/activity/p/36460/ Sat, 24 Jan 2026 04:48:52 -0500 There is emphasis on interpersonal skills for project managers. As cra24 explained, a well-rounded project team has members with diverse backgrounds and experiences who contribute to the outcomes or products. A project manager in the biomedical field should have the…   Read more»

]]> 1c54697abffbe2b06278cda1818dc181 https://medicaldevicecourses.com/activity/p/33687/ Sun, 16 Nov 2025 02:12:02 -0500 Risk management can be applied to supply chain efforts, considering that supply chain disruptions are usual in manufacturing at any time. The likelihood of supply chain disruption is higher, and the severity may be significant or severe depending on the…   Read more»

]]> b201204fa61db814487c76b7049a0e1d https://medicaldevicecourses.com/activity/p/33678/ Sat, 15 Nov 2025 05:14:21 -0500 FMEA is a recommended tool for identifying potential failures early in the development phase, as well as their effects and the recommended actions to be taken. Global organizations such as the Six Sigma Institute recognize FMEA as a critical tool….   Read more»

]]> 58a02c02adedbbcafe205f078fa97619 https://medicaldevicecourses.com/activity/p/33649/ Fri, 14 Nov 2025 03:34:09 -0500 Certain risks in medical device development can be mitigated but not eliminated. After the risk management plan is executed, the risk management team must measure the effectiveness of their plan. Residual risk refers to the remaining risk after strategies have…   Read more»

]]> 62115e308cd94c58b33e98fff6c945b1 https://medicaldevicecourses.com/activity/p/33575/ Sun, 09 Nov 2025 22:25:22 -0500 Yes, a smaller startup can benefit from efficiently using design controls. The advantage can start as early as the design planning and scope management phases. A smaller startup may be more likely to develop and execute a more custom project…   Read more»

]]> 1902744826c0735049a4a0eb791f12d5 https://medicaldevicecourses.com/activity/p/33555/ Sun, 09 Nov 2025 04:29:14 -0500 Successful process validation is intended to prevent product recalls, as there is evidence that the manufacturing process can be replicated while meeting all the requirements. For an original equipment manufacturer, increasing validation success requires the contract manufacturer (CM) and the…   Read more»

]]> 3fec23ec220eea6bef1e580651a79ff9 https://medicaldevicecourses.com/activity/p/33553/ Sun, 09 Nov 2025 01:52:17 -0500 Design transfer and process validation are closely related processes that require careful management from the right personnel. The design transfer must be completed so that the manufacturing stage can start. To prevent any issues or limitations, a contract review should…   Read more»

]]> 1edb06bb1e7a76b3bae27fb432918119 https://medicaldevicecourses.com/activity/p/33424/ Sun, 02 Nov 2025 03:53:51 -0500 Even though validation occurs later in the design controls process, it is based on the user needs, which are determined at the start of the process. Therefore, it would be beneficial to consider the required validation methods as early as…   Read more»

]]> 88b39869fdcf3b6ec7be606e1a55eae6 https://medicaldevicecourses.com/activity/p/33418/ Sun, 02 Nov 2025 00:42:48 -0400 The responsible persons have to research and collect data on user needs. They have to understand the user’s procedures and identify the risks & effects of the product. External factors like individual user performance can influence the product. This information…   Read more»

]]> 991893ecec0051e4a15b628c486a4559 https://medicaldevicecourses.com/activity/p/33387/ Fri, 31 Oct 2025 04:16:35 -0400 Medical device companies conduct internal audits to ensure compliance with regulations or standards. It is a great way to identify nonconformities before they become greater risks or to find ways for improvement. It is recommended for companies to conduct internal…   Read more»

]]> 28af626fa3d760d9be1e49cc5b86c5d9 https://medicaldevicecourses.com/activity/p/33323/ Mon, 27 Oct 2025 00:07:49 -0400 Medical device development takes several years to complete, and drug development can take over a decade to complete. The clinical trial process has become more complex and expensive, as mentioned. Challenges include the need for more procedures & tests, longer…   Read more»

]]> 5ee437d5bccec3634c31e1346a5e0754 https://medicaldevicecourses.com/activity/p/33319/ Sun, 26 Oct 2025 21:00:53 -0400 For the protection of human research subjects, regardless of the type of research, there is 45 CFR 46, which pertains to the Department of Health and Human Services. This regulation was also adopted by other agencies and departments, which is…   Read more»

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