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How can you overcome challenges when transferring a medical device design to manufacturing?

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Transferring a medical device design to manufacturing is a crucial step in the development process, but it can also pose many challenges. How can you ensure that your design meets the regulatory, quality, and performance standards of the market? How can you avoid costly delays, errors, and revisions that can compromise your project timeline and budget? How can you communicate effectively with your manufacturing partners and stakeholders? In this article, we will explore some strategies and tips to help you overcome these challenges and achieve a successful design transfer and manufacturing.

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Beat Keller

Compliant medical devices for a swift market access | Regulatory and Quality expert for a smooth go to market

1 Plan ahead

One of the key factors for a smooth design transfer is to plan ahead and anticipate the potential issues and risks that might arise during the manufacturing phase. This means defining the design specifications, requirements, and outputs clearly and accurately, and validating them with the appropriate testing and verification methods. It also means identifying the critical components, processes, and parameters that affect the safety and efficacy of the device, and establishing the control measures and acceptance criteria for them. Additionally, it means preparing the necessary documentation, such as design history files, risk management files, and technical files, to demonstrate compliance with the regulatory and quality standards of the target market.

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Jo?o Oliveira

Engenheiro Biomédico | Engenheiro Clínico | Gest?o de Tecnologias em Saúde | Engenheiro de Seguran?a do Trabalho
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Planejar com antecedência é fundamental para assegurar uma transferência de projeto eficiente, especialmente durante a fase de fabrica??o. Isso envolve uma defini??o clara e precisa das especifica??es, requisitos e resultados do projeto, validando-os por meio de métodos de teste e verifica??o apropriados. Antecipar potenciais problemas e riscos é essencial, identificando componentes, processos e parametros críticos que impactam a seguran?a e eficácia do dispositivo. Estabelecer medidas de controle e critérios de aceita??o para esses elementos contribui para mitigar possíveis desafios.

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2 Choose the right manufacturer

Another important factor for a successful design transfer is to choose the right manufacturer for your device. This means selecting a manufacturer that has the experience, expertise, and capacity to produce your device according to your specifications and standards. It also means evaluating the manufacturer's quality system, processes, and capabilities, and ensuring that they are compatible with your design requirements and outputs. Furthermore, it means establishing a clear and transparent contract, scope of work, and responsibilities with the manufacturer, and defining the roles, expectations, and deliverables for both parties.

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3 Collaborate and communicate

A third essential factor for a smooth design transfer is to collaborate and communicate effectively with your manufacturing partners and stakeholders. This means involving them early and throughout the design process, and soliciting their feedback and input on the design decisions and changes. It also means maintaining regular and open communication with them, and updating them on the progress, issues, and solutions of the design transfer and manufacturing. Moreover, it means establishing a common language and terminology, and using the appropriate tools and platforms to share information and data securely and efficiently.

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4 Monitor and control

A final crucial factor for a successful design transfer is to monitor and control the manufacturing process and output. This means setting up and implementing a robust quality plan, system, and audit to ensure that the manufacturing process meets the design specifications, requirements, and outputs. It also means conducting inspections, tests, and validations to verify that the manufactured device conforms to the regulatory, quality, and performance standards of the market. Additionally, it means tracking and documenting the manufacturing activities, results, and deviations, and applying corrective and preventive actions when necessary.

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5 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?

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Beat Keller

Compliant medical devices for a swift market access | Regulatory and Quality expert for a smooth go to market
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Another important point is to have a quality agreement in place, if manufacturing is outsourced. This agreement should define, how changes can be introduced from both sides, the legal manufacturer and the contract manufacturer. Contract manufacturers often like to change production process details to optimize workflow or to use second source parts which might have an influence on performance or safety/biocompatibility of the medical device. One point that we see gets often overlooked are the requirements from the regulators such as the right to audit (announced and unannounced) at the contract manufacturer by the authority or notified body or the registration requirements such as the establishment license required for contract manufacturers

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How can you overcome challenges when transferring a medical device design to manufacturing?

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3

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1 Plan ahead

2 Choose the right manufacturer

3 Collaborate and communicate

4 Monitor and control

5 Here’s what else to consider

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