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Samiha Khan replied to the topic "Confidentiality Agreements" – 4 months, 2 weeks ago
It is essential to address important points when establishing a consulting agreement with a consulting firm to protect a company’s interests and ensure clarity in collaboration. In addition to specifying who will own any intellectual property created during the involvement,… Read more»
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Samiha Khan posted a new topic "AdvaMed Guidelines & Fair Market Value" – 4 months, 2 weeks ago
Fair market value compensation for healthcare professionals is an underscored term in AdvaMed guidelines to minimize a substantial impact on the purchase or promotion of devices. Which paperwork generally is required to verify compliance, and how is “fair market value”… Read more»
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Samiha Khan posted a new topic "Conflict Resolution in Contract Law" – 4 months, 2 weeks ago
Complex medical device contracts are full of conflicts. Maintaining company stability depends on effectively resolving them. Which conflict resolution strategies are applied in consulting agreements in the medical device industry? How can jurisdiction conditions, arbitration, or mediation be modified to… Read more»
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Samiha Khan posted a new topic "Value-based healthcare: "Dos and Don'ts"" – 4 months, 3 weeks ago
The companies need to adjust their operations to meet new market expectations as healthcare systems shift toward value-based care. What organizational development strategies can medical device companies implement to satisfy the growing demand for value-based healthcare?
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Samiha Khan posted a new topic "AI & IoT in medical device industries." – 4 months, 3 weeks ago
Implementation of advanced technologies demands established development frameworks and organizational adaptability. Which function does organizational development play in assisting medical device manufacturing companies to incorporate cutting-edge technology like AI and IoT?
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Samiha Khan replied to the topic "Upper vs Middle Management." – 4 months, 3 weeks ago
I would like to prefer middle management based on my personality and talent as I function my best in roles that allow me to transform strategic visions into practical activities, bridging the gap between high-level strategies and daily operations. My… Read more»
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Samiha Khan posted a new topic "Residual risk during device development" – 5 months ago
How do you determine the acceptable level of residual risk when developing medical devices, particularly when balancing patient safety, technological feasibility, and financial constraints? When justifying risk acceptance decisions to regulatory agencies like the FDA or following international standards such… Read more»
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Samiha Khan replied to the topic "Risk Acceptance" – 5 months ago
While risk acceptance can be a valid strategy in risk management, it must be approached with caution when developing medical devices. Only hazards that pose a low risk of occurrence and have minimal impact should be considered for acceptance. Risks… Read more»
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Samiha Khan replied to the topic "To risk manage or not to risk manage?" – 5 months ago
Risk management is an essential component in medical device development to ensure patient safety, regulatory compliance, and product quality. Manufacturers can proactively identify, evaluate, and mitigate potential risks early in the development phase to avoid expensive recalls, redesigns, and legal… Read more»
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Samiha Khan replied to the topic "Design Verification vs. Validation" – 5 months, 1 week ago
Both design validation and verification serve as the vital steps in the medical device development since they maintain both product quality and regulatory compliance. Regulations such as, FDA QSR and ISO 13485 involve them, and they need detailed records showing… Read more»
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Samiha Khan posted a new topic "Design Transfers to Contract Manufacturers" – 5 months, 1 week ago
What particular issues or limitations are required to be taken into consideration when transferring design control and standards to any contract manufacturer?
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Samiha Khan posted a new topic "Risk Management in Verification & Validation" – 5 months, 1 week ago
What techniques are applied to coordinate risk evaluations with design verification and validation results, and how does the risk management effect these tasks?
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Samiha Khan posted a new topic "Details needed in a DHF for complex devices" – 5 months, 2 weeks ago
The Design History File (DHF) may become huge and difficult to handle for complex devices. How do you make sure that the DHF has all the information you need without being overwhelming? Do you have any advice on how to… Read more»
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Samiha Khan replied to the topic "Medical Device Clinical Trials vs Drug Trials" – 5 months, 2 weeks ago
Despite having the same objective of evaluating safety and efficacy, drug and medical device studies differ widely in terms of their focus, objectives, and structure. The methodology used in drug trials is linear and phase-based, with each stage building on… Read more»
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Samiha Khan replied to the topic "Validation vs Verification" – 5 months, 2 weeks ago
Though I don’t have industry work experience, from my understanding- verification ensures that a product is constructed accurately and accordingly with its design requirements. To verify compliance with the standards, laws, and physical characteristics specified in the design documents, testing,… Read more»
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Samiha Khan replied to the topic "Ethical Challenges of AI in Clinical Trials" – 5 months, 3 weeks ago
Although AI has quite a lot of potential to benefit clinical trials, there are ethical questions it brings up as well. These include bia…[Read more]
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Samiha Khan posted a new topic "Challenges faced in patient recruitment, how can CROs and CRAs address them?" – 5 months, 3 weeks ago
One of the major challenges in clinical trials persists in patient recruiting, which typically results in research time delays. Which strategies are often utilized by CRAs and CROs to improve selection? What effects do geography, culture, and medical conditions have… Read more»
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Samiha Khan posted a new topic "Patient safety and data integrity during clinical trials" – 5 months, 3 weeks ago
Ensuring the safety of healthy volunteers and patients taking part in clinical trials is vital. Another essential component of clinical studies is data integrity. What are the primary ethical and regulatory guidelines (such as ICH and GCP) that CRAs and… Read more»
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Samiha Khan replied to the topic "Difference between Product Development and Product Management" – 6 months ago
The choice between Product Development and Product Management depends on individual interests and skills. If someone enjoys technical aspects and problem-solving, product development might be a better fit. If someone prefers strategic thinking and cross-functional collaboration, product management is a… Read more»
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