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在iec62304這個產品中，有2篇Facebook貼文，粉絲數超過7,185的網紅自強基金會，也在其Facebook貼文中提到， 👥醫療器材課程交給自強最專業🥳 價格也非常可以👌👌 CP值超高🆙🆙 🧑‍🔬歐美IVD管理法規與緊急專案送審(EUA)規範與實例 https://bit.ly/2V5OWV7 🧑‍🔬醫材製程確效與軟體確效-品質管理系統 http://bit.ly/3nBQQso 🧑‍🔬IEC6230...

iec62304 在 自強基金會 Facebook 的最佳貼文

自強基金會 By 自強基金會

2021-01-19 19:25:42 有 4 人按讚
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👥醫療器材課程交給自強最專業🥳
價格也非常可以👌👌
CP值超高🆙🆙
　　
🧑‍🔬歐美IVD管理法規與緊急專案送審(EUA)規範與實例
https://bit.ly/2V5OWV7
　　
🧑‍🔬醫材製程確效與軟體確效-品質管理系統
http://bit.ly/3nBQQso
　　
🧑‍🔬IEC62304醫材軟體生命週期
https://bit.ly/3ia0n8S
　　
　　

#生物醫學課程
#醫材課程
#醫材法規
#IVD管理法規
#緊急專案送審(EUA)
#品質管理系統
#醫材製程確效
#軟體確效
#IEC62304
#醫材軟體生命週期

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以科技產業的知識學習中心及促進產業技術升級的平台為核心價值，協助學員提昇工作技能及取得新技術、新觀念，使工作中之學習能有所成果。多元化的課程規劃及專業的師資，完整提供科技產業需求與科技人力。
生活，就是開創人生更多值得紀念的時刻。每個時期的成長，默默耕耘，總會收穫。無論時局如何變化，自強一直會在這裡，陪您走過人生的每個階段!
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iec62304 在 COMPOTECHAsia電子與電腦 - 陸克文化 Facebook 的精選貼文

COMPOTECHAsia電子與電腦 - 陸克文化 By COMPOTECHAsia電子與電腦 - 陸克文化

2020-12-18 14:30:01 有 83 人按讚
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#嵌入式系統 #微控制器MCU #數位訊號控制器DSC #功能安全 #ISO26262 #IEC61508 #IEC60730 #IEC62304

【不可不知：功能安全】

最終產品的堅固性、可靠性和安全性變得越來越重要。在某些應用領域中，這些要求是形式化和強制性的；而在另一些應用領域中，則透過這些要求來區分產品的優劣度。

「功能安全」標準取決於目標市場。許多標準支援多種級別的嚴格性，具體程度取決於危害的可能性和嚴重性，範圍包括單一故障、嵌入式系統的安全狀態到完全冗餘，不僅應檢測故障，還應校正故障以防服務中斷或降級。

延伸閱讀：
《Functional Safety for ISO 26262, IEC 61508, IEC 60730 and IEC 62304》
https://www.microchip.com/design-centers/functional-safety?utm_source=compotechasia.com&utm_medium=LeaderboardAd&utm_content=Corp_860x80&utm_campaign=FunctionalSafety

#微芯科技Microchip #AVR #PIC24 #dsPIC #SAM #PIC32

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2002年，憑藉獨特敏銳度察覺到電子業界需求，《COMPOTECHAsia電子與電腦》於中國大陸取得《COMPOTECHChina》月刊發行權，為初到海外發展及當地讀者出具最具前瞻性且中肯的觀察，具有相當影響力，也成為一流國際大廠競相展示研發心血的首選。 2006年，有鑑於網路環境日趨成熟，《COMPOTECHAsia電子與電腦》再度領先同業，首創線上視頻平台CTOV (COMPOTECH Online Video)。自此，成為整合紙本、網站、電子報及線上視頻的全方位媒體。 2016年，為貫徹市場應用及開發技術的連結並擴大群眾基礎，陸續展開 Facebook、Twitter、LinkedIn 等社群平台經營。 「就市論勢、就勢論市」是我們的信念。我們將於每週一、三、五下午在 FB 分享生活中隨處可見的科普知識，以平易近人的方式，用不一樣的角度觀察市場趨勢和技術走向，並不定時穿插轉載網路精彩佳作或趣聞。記得設為「搶先看」哦！ “COMPOTECHAsia/ China” issue on 8th monthly. It is the dependent media which focuses on electronic industry situation, end user market, and technology trend. The monthly magazine has become the main channel to get professional information for engineers, purchaser, R&D employees and decision-making management. We perceived the demand of electronic industry and strive to get the distribution rights of “China Edition” in Mainland China in 2002. It gives a lot of prospective and proper observation for the overseas workers and local readers. Gradually, COMPOTECH is getting to be the powerful. Nowadays, COMPOTECH is the first-choice platform for the first-class firms to display their R&D results. Furthermore, in 2006, we were ahead of our competitors to build the CTOV platform (COMPOTECH Online Video) due to the mature internet environment. Since then, COMPOTECH has become the integrated media. For having a thorough knowledge of market applications and technology migration, as well as expanding the base of the masses, we begin to manage the Facebook, Twitter and LinkedIn etc. in 2016.
智能系統設計／應用工程師、產品／專案開發主管、元器件／零組件／準系統採購者的交流園地，於每週一、三、五下午分享【科技應用取向】的趨勢議題。
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iec62304 在 ‪#‎iec62304‬ - Explore | Facebook 的推薦與評價

explore #iec62304 at Facebook. ... first line of defense to fix bugs and achieve IEC 62304 compliance for the safe development of medical device software? ... <看更多>

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#1. IEC 62304 醫療器材軟體| TÜV SÜD

根據IEC 62304合格標準規定，醫療器材驗證範圍涵蓋獨立軟體和醫療器材嵌入軟體兩大方面。IEC 62304, Medical Device Software, medical device functional safety ...

#2. IEC62304 醫療器材軟體確效法規與實務 - 產業學習網

IEC62304 醫療器材軟體確效法規與實務 ... 醫療器材軟體功能安全說明; 醫療器材軟體測試與確效; 醫療器材相關標準; IEC 62304標準重點與實務; 美國FDA軟體確效 ...

#3. IEC 62304:2015 醫療軟體確效法規與實務

IEC 62304 – medical device – software life cycle processes. • IEC 60335-1 Annex R, IEC 60730-1 Annex H. Master of Automation and Control. Qualifications.

#4. IEC 62304 - Wikipedia

The international standard IEC 62304 – medical device software – software life cycle processes is a standard which specifies life cycle requirements for the ...

#5. IEC 62304:2006+AMD1:2015 CSV Consolidated version

IEC 62304 :2006+A1:2015 Defines the life cycle requirements for medical device software. The set of processes, activities, and tasks ...

#6. IEC 62304:2006 - Medical device software - ISO

Defines the life cycle requirements for medical device software. The set of processes, activities, and tasks described in this standard establishes a common ...

#7. IEC 62304醫材軟體生命週期管理之防疫實際運用探討 - FIND

由國際電工委員會（International Electrotechnical Commission, IEC）制定的IEC 62304醫材軟體生命週期標準，由於醫材軟體生命週期攸關病人健康和醫 ...

#8. What Is IEC 62304? Medical Device Software Compliance Tips

IEC 62304 is a functional safety standard that covers safe design and maintenance of software. It provides processes, activities, and tasks to ...

#9. IEC 62304 | Greenlight Guru

IEC 62304 is an international standard medical device software that defines an agreed upon framework for processes that occur throughout the product lifecycle.

#10. IEC62304 醫療設備軟體認證服務

該服務涵蓋按照IEC 62304標準的品質管制體系檔和特定產品的生命週期文件的審核。評估的基礎是符合IEC 62304標準的軟體生命週期的文件，建立在符合ISO 13485的品質管理體系 ...

#11. IEC-62304対応 イーコンプライアンス

IEC62304 （Medical device software - software Life Cycle Processes）は、 医療機器ソフトウェアの安全性の向上を目的として、ソフトウェア開発及び保守に関する要求 ...

#12. IEC62304及IEC82304-1 醫療軟體管理簡介 - 展會與研討會

本課程以IEC 62304及IEC82304-1為主軸提供一個醫療相關軟體開發必要的基本安全設計概念。這方面的能力將可幫助管理產品時更加具有經濟與效益。

#13. What Is IEC 62304 & How Is It Used in Medical Device ...

IEC 62304 is a safety standard for medical devices, and compliance with it is critical to software developers. Whether it's a doctor, a ...

#14. IEC 62304 standard for medical device software development

IEC 62304 is an international standard published by the International Electrotechnical Commission (IEC) that defines the requirements of the software ...

#15. ‪#‎iec62304‬ - Explore | Facebook

explore #iec62304 at Facebook. ... first line of defense to fix bugs and achieve IEC 62304 compliance for the safe development of medical device software?

#16. IEC 62304 | FDA Software Validation Compliance - QA Systems

IEC 62304 :2006 (Medical Device Software- Software Life-cycle Processes) is a functional safety standard. A system to which IEC 62304 is applicable often has ...

#17. ANSI/AAMI/IEC 62304:2006 - Medical device software

ANSI/AAMI/IEC 62304:2006. Medical device software - Software life cycle processes. This standard defines the life cycle requirements for MEDICAL DEVICE ...

#18. 醫療器材軟體IEC 62304標準概述 - 璞旭顧問

國際標準IEC 62304主要是針對醫療器材軟體所做的生命週期流程管理，適用範圍包括了純醫療軟體及嵌入或整合於醫療器材上的軟體。醫療器材製造商應提供 ...

#19. IEC 62304 | Auriga

IEC 62304 case studies and software development and testing projects by Auriga Inc.

#20. What is IEC 62304? | KO2 Recruitment

IEC 62304 offers guidance on how to identify potential hazards that could be the result of medical software failures or defects, and therefore outlines how to ...

#21. Embedded RTOS with IEC62304 certified - ResearchGate

Download scientific diagram | Embedded RTOS with IEC62304 certified from publication: Embedded operating system and industrial applications: A review | The ...

#22. IEC 62304 ed. 2 – what happened? - LinkedIn

It may sound improbable, but expanding the scope of IEC 62304 from medical device software to health software turned out to be a more ...

#23. Applying IEC 62304 From a Medical Device Perspective | UL

IEC 62304 is a functional safety standard that defines the life cycle requirements for medical device software providing processes, activities ...

#24. IEC 62304 - 视觉解决方案

IEC 62304. 软件已成为大多数医疗设备不可或缺的一部分。 因此，医疗设备制造商必须能够证明包含软件的医疗设备的安全性和有效性。 IEC 62304 标题为“医疗器械软件—— ...

#25. IEC 62304:2021 Committee Draft Version: Groundhog Day

That's a déjà-vu. The second version of IEC 62304 is still in draft. It has been in this state for five years, since the publication of the ...

#26. IEC 62304:2015 | Medical Device Software Standards

IEC released amendment 1 for IEC 62304 in June of 2015. The purpose of this revision was: Additional requirements to address software life cycle processes ...

#27. IEC60601 / IEC62304 / IEC 62366 | DH RegSys Pte Ltd

IEC60601 / IEC62304 / IEC 62366. Interdependence and interactions of various standards to support medical device development.

#28. 醫療器材軟體應用、驗證及確效

IEC 62304 :2006/Amd. 1:2015. Class A：. 軟體系統可能會導致危. 害情況，不會導致不可. 接受的風險。 Class B：. 軟體系統可能導致危害情況，. 可能產生危害是非嚴重傷害 ...

#29. IEC62304醫療設備/軟體輔導認證費用 - 萬弘資訊顧問有限公司

2021年3月9日更新：IEC62304醫療設備/軟體輔導認證費用，輔導費用:新台幣42-50萬，認證費用20-26萬間（依產品別、複雜度、韌體、軟體、硬體的規格 ...

#30. IEC 62304 Consultancy & Training Course

IEC 62304 Health Software ✓software lifecycle ✓embedded ✓standalone ✓consultancy ✓support ✓training courses. Lorit Consultancy – your partner for ...

#31. IEC 62304 Medical Device Software Development - Pro4People

Developing IEC 62304 compliant software for medical devices, in line with its intended use and compliant with ISO 13485, ISO 14971, and IEC 62304 standards.

#32. Meeting IEC 62304:2006 Requirements with GitLab

IEC 62304 :2006 defines requirements for the lifecycle of medical device software. It prescribe processes, activities, and tasks to improve the safety and ...

#33. LDRA Medical software application | IEC 62304 | FDA

LDRA's tool suite is a software verification and validation solution for the development of medical device software that meets FDA and IEC 62304 standards.

#34. How we organise around IEC 62304 | In The Pocket

IEC 62304 is inevitable when developing medical devices. How do we bring agility into the process?

#35. IEC 62304:2006/AMD1:2015 - Amendment 1 - iTeh Standards

IEC 62304 :2006/AMD1:2015 - Amendment 1 - Medical device software - Software life cycle processes.

#36. Software & IEC 62304 - Johner-Institut

Die IEC 62304 ist eine in Europa harmonisierte Norm für „Medizingeräte-Software“. Sie stellt Mindestanforderungen an die wichtigsten Software-Lebenszyklus- ...

#37. IEC 62304 | Vector

VectorCAST products help satisfy FDA - IEC 62304 software testing requirements.

#38. IEC 62304: the requirements of this Medical Device Software ...

The IEC 62304 standard introduces 3 software safety classes, from A (the least crucial) to C (the most crucial). Depending on the cruciality, the lifecycle of ...

#39. The Importance of IEC 62304 Compliance - SoftComply

IEC 62304 outlines the guiding principles for the development of medical software. It is the gold standards for medical device companies, ...

#40. Achieve Fast Compliance with IEC 62304 - Polarion - Software

IEC 62304 Solution Benefits: Prove the implementation of processes, actions and approvals; Track all actions at a forensic level throughout the entire ...

#41. 行业认证标准：IEC 62304-医疗设备软件安全分类标准 - CSDN ...

什么是IEC 62304？IEC 62304标准在医疗设备行业中使用，它是一种软件安全分类，它为软件生命周期过程提供了一个框架，其中包含为安全设计和维护医疗 ...

#42. Which OS for IEC 62304 Medical Systems? - BlackBerry QNX

It lists requirements identified by standards such as IEC 62304, ISO 14971 and IEC 61508, and offers comparative estimates of the effort required to meet ...

#43. Medical Device Software & IEC 62304 - Johner-Institut

Medical device software has to be developed according to the FDA and IEC 62304 requirements. Find out how to fulfill these requirements efficiently and ...

#44. IEC 62304 - Wikiwand

The international standard IEC 62304 – medical device software – software life cycle processes[1] is a standard which specifies life cycle requirements for ...

#45. IEC 62304 Ed. 2: Software Life Cycle Standard for ... - PubMed

The quality of software is high in medical devices due to the strict regulatory requirements and their implementation in the software ...

#46. Compliance with IEC62304 - Microsoft Q&A

Compliance with IEC62304. hello,. I am working as Software validation engineer in Medical device Industry. Development team uses Visual ...

#47. IEC 62304: Medical Device Software LifeCycle Processes

IEC 62304 is the international standard for medical device software development and other medical device software life cycle processes. Every ...

#48. IEC62304 - Aligned AG

"No, IEC 62304 is a process standard and as such “only” define expectations on activities and their corresponding outputs. The key scope of IEC62304 is the ...

#49. Is Google Unit Test compatible with IEC 62304? - Stack Overflow

IEC 62304 is a software life cycle process, it has nothing to say about whether you can or cannot use a particular tool, only the steps ...

#50. IEC 62304 & ISO 13485 Relationship - I3CGLOBAL

IEC 62304 must be applied in conjunction with ISO 13485 standard which offers a framework for the lifecycle processes necessary for the safe design & risk.

#51. IEC62304 医療機器ソフトウェアライフサイクルプロセス

IEC 62304 :2006(JIS T 2304:2012) は、高品質で安全な医療機器ソフトウェアを常に製造する開発プロセスを示すことを目的としている。この目的を達成するために、 ...

#52. Writing Software Requirements Based on the IEC 62304

The IEC 62304:2006 lists a number of software requirement categories. It makes a lot of sense for you to use those as this enables you to somewhat prove that ...

#53. 活動訊息_醫療器材軟體確效實務

本課程將以IEC 62304 之要求為主軸，介紹醫療器材軟體生命週期過程之必要元素，並以實務方式說明軟體確效之內容，同時介紹美國FDA 對軟體及行動裝置醫用 ...

#54. 【工研院課程】IEC62304 醫療器材軟體確效及生命週期

軟體確效(Software Validation)已成為各國醫療器材主管機關關注的重點。目前美國、歐盟與我國均要求業者在上市前申請時需提交醫療器材軟體確效報告，熟知醫療器材軟體確效 ...

#55. IEC 62304 - Elucidating Medical Device Software Guidelines ...

IEC 62304 is a functional safety standard similar to IEC 61508. You can learn the fundamentals of IEC 62304 through this article and much ...

#56. IEC62304-2006解讀 - 台部落

IEC62304 強調醫療軟件在明確和滿足其預期用途的前提下，不能引發不可接受的風險62304提供一個醫療軟件開發的框架，並指出框架下每個過程的要求，62304 ...

#57. IEC62304(software軟體確效) - 今日商機王

聯絡資訊. 機關名稱: 國立臺灣大學. 單位名稱: 資訊電子科技整合研究中心. 機關地址: 106臺北市大安區羅斯福路4段1號博理館429室. 聯絡人: 康毓珊.

#58. IEC62304 2006 CheckList | PDF | Risk Management - Scribd

IEC62304 -2006-CheckList-xls - Free download as PDF File (.pdf), Text File (.txt) or view presentation slides online. checklist requirements 62304.

#59. IEC 62304 | SYSGO

IEC 62304 Certification Standard. Functional Safety in the Medical & Healthcare industry is certified according to IEC 62304, a standard for the software life- ...

#60. IEC 62304 Ed. 1.0 b:2006, Medical device software - Amazon ...

IEC 62304 Ed. 1.0 b:2006, Medical device software - Software life cycle processes [IEC TC/SC 62A] on Amazon.com. *FREE* shipping on qualifying offers.

#61. FDA and IEC 62304 Software Documentation

This post summarizes how to satisfy both FDA guidance and IEC 62304 for your software regulatory submission.

#62. 醫療裝置軟體國際標準IEC 62304認證案例_旋極科技

為了符合IEC 62304標準對嵌入式軟體單元測試框架的要求，FastFocus提出了一套嚴格的工具需求。他們需要一個值得信賴的供應商，可以提供高效的技術 ...

#63. Klocwork 2019.3 ISO 26262, IEC 61508, IEC 62304, and EN ...

IEC 62304 ; EN 50128. The Functional Safety standard IEC 61508 for Automotive Electric/Electronic Systems covers numerous activities and processes in the ...

#64. Developing Medical Device Software According to IEC 62304

Learning Objectives · Detailed understanding of IEC 62304 · Software Development Processes for Medical Devices · Software Maintenance Processes for Medical Devices ...

#65. IEC 62304 standard and software safety classifications

If you are developing medical device software, then you will be working closely with the IEC 62304 standard. The number of activities you ...

#66. IEC 62304 - Recognized Consensus Standards - US Food ...

IEC 62304 :2006+A1:2015 Defines the life cycle requirements for medical device software. The set of processes, activities, ...

#67. IEC 62304, EN 62304...Confused? - Wind River Blog

Both, IEC 62304 and EN 62304, share the same genealogy and are well recognized software life cycle standards. The only difference is that they ...

#68. 醫療器材軟體確效實務 - 國立清華大學

醫療器材全生命週期從設計開發到產品上市後，均已要求製造業者必須建立軟體全生命週期管理流程，而具體的要求則於IEC 62304標準中以五項主要流程規範軟體生命週期活動 ...

#69. IEC 62304 - for safety class A, class B and class C | Axivion

IEC 62304 describes the Software life cycle processes containing the Development and Maintenance Process, Risk Management (incorporating ISO 14971 and the ...

#70. Implementing IEC 62304 for Safe and Effective Medical ...

In response to that, the functional safety standard IEC 62304, “Medical device software – Software life cycle processes,” has emerged as an ...

#71. 什麼是IEC 62304？如何用它滿足醫療器械安全合規性？ - 資訊咖

IEC 62304 是醫療設備的安全標準，遵守該標準對軟體開發商至關重要。無論是醫生、專家還是護士，醫療保健提供者都依賴醫療設備來治療他們的病人。

#72. IEC/EN 62304 Medical Device - Software Life Cycle Processes

DO-178C · EN 50128 / IEC 62279 · IEC 60880 · IEC 61508 · IEC 62304 · IEC 62443 · ISO 26262 · Functional Tests · Static Code Analysis · MISRA ...

#73. IEC62304:2015 是什么标准？ - 百度知道

IEC62304 :2015 是什么标准？ 我们是研发体外医疗器械的，会软件这一块，请问要不要参照IEC62304:2015作为标准...

#74. IEC 62304 Class A Project - Elsmar Cove

Huray. The thing now is that my boss sold our customer IEC62304 documentation so our customer can get through the audit. So.. now i have to make ...

#75. Risk based software verification - ISO14971 and IEC62304

Risk based software verification - ISO14971 and IEC62304. 15 January 2014, Palo Alto, United States. Introduction. Get trained on how to define the residual ...

#76. Software Life Cycle for Medical Devices: IEC 62304

IEC 62304 then requires a systematic analysis of problems and changes that have occurred in connection with the software application. This ...

#77. IEC62304/美國FDA Guidance醫療器材軟體確效及實務經驗分享

核心議題四-IEC62304/美國FDA Guidance醫療器材軟體確效及實務經驗分享 ... 相關醫護人員與學生了解具體的EN/IEC 62304及醫療器材電性安全要求規範。

#78. Best Practices: IEC 62304 Compliant Medical Device Software

If you are developing a new product, learn more about Best Practices for Medical Device Software Developed under IEC 62304.

#79. IEC 62304 2015 - impact on Class A software - Matrix ...

You need to do the following if you choose to use IEC 62304: there must be tests cases for the software requirements; you need to manage issues ...

#80. IEC 62304 | ArrowFast MedTech Glossary

IEC 62304 is a standard that defines the life cycle requirements for software that is used in a medical device.

#81. Static Analysis and IEC 62304 - GrammaTech Blog

Applicability to Medical Device Software · Section 5.5.2 of IEC 62304 requires a software unit verification process: The MANUFACTURER shall ...

#82. Medical Device Software, Risk Management & IEC 62304 |

The international standard IEC 62304 Medical Device software – software life-cycle processes is the main framework for requirements for the ...

#83. White Paper - Implementation of ANSI/AAMI/IEC 62304 ...

This paper reviews the implementation of the ANSI/AAMI/IEC 62304 Medical Device Software – Software Life Cycle Processes standard.

#84. SEPT IEC 62304 Checklist - Techstreet

IEC 62304 :2015, Medical Device Software - Software Life Cycle Processes.

#85. IEC 62304 Medical Device Software - Know-how Set - ins2outs

Learn about IEC 62304 Know-how Set. It specifies Software Development Life Cycle (SDLC) processes required for developing health software.

#86. Medical Devices & Applications testing- standards compliance ...

IEC 62304 is applicable to all software for medical devices and applications and covers the processes and activities around the production of embedded and ...

#87. IEC 62304 Compliance Software - ALM Software Tool - Orcanos

IEC 62304 Defines the life cycle requirements for medical device software. The set of processes, activities, and tasks described in this standard ...

#88. Software Tools Cut A Path To IEC 62304 Compliance - Fierce ...

LDRA introduces its tool suite for Medical Devices, a variation of its LDRA tool suite, tailored to help companies achieve IEC 62304 ...

#89. 医療機器ソフトウェアSLCP支援ソリューション - テク ...

IEC 62304 への準拠、ライフサイクルプロセスの効率化や自動化、または医療機器ソフトウェアに関するMDD、MDR、FDA、CFDA申請に向けたソリューションを提供します。

#90. What is IEC 62304 -standard? | Kasve Ltd

IEC 62304 defines the set of processes for life-cycle management of medical device software.

#91. Medical Device software development, IEC 62304 & asking ...

For IEC 62304, it is also important to consider software safety as part of the overall device risk management. In many cases, the software will ...

#92. 醫電設備軟體確效IEC62304理論與實務NEW! | 活動快報

一、 IEC 62304 五大流程要求與解釋. 二、 軟體確效報告實務(FDA Software pre-submission guidance). 三、 USFDA SaMD 與 AI軟體指引文件說明. 招訓對象.

#93. FDA Guidance on IEC 62304 Software Standard - Plianced Inc.

The international standard IEC 62304 software life cycle processes is a standard which specifies life cycle requirements for the development ...

#94. IEC62304:2006 Archives - StarFish Medical

IEC62304 :2006 calls this “Software of Unknown Provenance” or SOUP, referring to software with unknown safety-related characteristics, or developed under an ...

#95. 5 Major IEC 62304 Compliance Mistakes Medical Software ...

The international standard IEC 62304 is a standard that specifies life cycle requirements for the development of medical software.