Manasi - 生物醫學工程師助理 AI Skill
$29.00
特價
$29.00
原價
跳至產品資訊
Start All-Access
Manasi - 生物醫學工程師助理 AI Skill
$29.00
this skill
vs
$120+/hr
hiring a medical device regulatory engineer
Complete skill package instant downloadmanasi-biomedical-engineer-assistant.txt
Choose how to get it
Start All-Access, from $8.25/mo$99 a year, or $19 a month. 14-day refund on the first charge.
// all-access
You do not download skills. Your AI fetches them.
The KissMySkills connector is a small server your AI chat talks to. Add it once to Claude, ChatGPT, Claude Code or Cursor. From then on, any of our 1,000+ skills is one sentence away.
- 01Add the connector. Settings, Connectors, paste one link. A minute.
- 02Sign in once. The email from your subscription. Nothing installs.
- 03Ask for a skill. "Load Manasi." It arrives in the conversation and your AI answers as that specialist.
$99/yr $8.25 a month
$19/mo month to month
Every skill, prompt pack and agent, new releases included. Single files can still be bought and kept. Cancel any time from your account. Compare plans
Secure checkout by Shopify
⚡ 立即下載
∞ 永遠保留
✎ 由我們撰寫
Add it once. Your AI works like a specialist.
將其加入 Claude、ChatGPT 或 Gemini - 您的 AI 會在此領域中擔任專家。
立即下載 · 30 天退款保證。 一次付費，永久使用 - 無需訂閱。由我們撰寫並測試，絕非從 GitHub 抓取。 退款政策
Ask Manasi something hard.
We are adding Bluetooth to an existing Class II device. Is that a letter to file or a new 510(k), and what testing do we need?
CLAUDE · AS MANASI, 生物醫學工程師助理
You get: three questions first, because the answer depends on whether the wireless link carries any control function, whether the indications for use change, and what your existing 510(k) claimed -> then the change assessment run against the FDA guidance decision flow, with the two branches that push it to a new submission called out explicitly -> then the testing that follows either way: IEC 60601-1-2 edition 4.1 immunity retest because the radio changes the emissions and immunity picture, IEC 62304 impact analysis with the software safety class re examined, and a cybersecurity documentation package under the premarket guidance -> then the risk file updates, new hazards from wireless loss and pairing error, with risk controls traced to verification -> then the DHF sections that need revision and the change record entry -> then a note that your regulatory lead of record signs the decision, and that nothing here is clinical advice.
Trademarks of their respective owners. KissMySkills is not affiliated with or endorsed by them.
你不需要閱讀。由你的 AI 代勞。
只需將技能檔案新增至 Claude、ChatGPT 或 Gemini 一次。從那之後，它就會以這個領域的專家身分運作，並從下一則訊息開始以 Manasi 的身分回答。
購買一次，檔案便永久歸您所有。或者訂閱 All-Access，讓 KissMySkills 連接器在您提出要求時，將該檔案及其他所有技能載入您的聊天中。
// what's inside
這項技能包含什麼
- Structures design controls to 21 CFR 820.30 and ISO 13485 with a real traceability matrix
- Picks predicates on indications for use, not on technology that merely looks similar
- Runs ISO 14971 risk management before design freeze, not as a document written after
- Maps testing to IEC 60601-1, IEC 62304 software class and ISO 10993 biocompatibility
Device engineers, regulatory and quality staff at small manufacturers, and startups taking a first Class II product through design controls and a 510(k).
// what's inside
What you're actually buying
設計歷史檔案中，本應放置設計輸入的地方卻出現了缺口，而稽核員會在你之前發現它。醫療器材專案很少敗在工程本身，而是敗在工程紀錄上。這份檔案賦予你的助理受監管開發實際依賴的生物醫學工程技能：設計管制、同類器材策略、將驗證與確效分開，以及在設計仍持續變動時就開始撰寫的風險檔案。
它會先詢問器材類別、預期用途聲明與目標市場，因為美國 Class II 510(k) 與歐盟 MDR 技術檔案是不同的專案，需要不同的證據。接著，它會使用送件語言運作：使用適應症，而非行銷宣稱；依 IEC 60601-1 界定基本性能；依 IEC 62304 界定軟體安全等級並聲明 SOUP；依 ISO 10993-1 規劃生物學評估，而不是反射性地進行細胞毒性測試；並追溯從危害到完成驗證的風險控制措施。
單一檔案、單次付款、無訂閱。載入 Claude、ChatGPT 或 Gemini 約需兩分鐘。
# Manasi, Biomedical Engineer Assistant KissMySkills.com | Install: paste this whole file into Claude Projects (Project instructions), a custom GPT (Instructions), a Gemini Gem, or your AI's system prompt. Then just ask for what you need. ## Who you are You are a medical device engineer with eleven years in Class II and Class III development, across design assurance, regulatory affairs and quality. You optimise for a file that survives an audit and a submission that clears on the first cycle. You write in the vocabulary of the record: inputs, outputs, traceability, objective evidence. You support engineering and documentation only, never clinical decisions. ## What you know - Design controls under 21 CFR 820.30 and ISO 13485 clause 7.3: user needs, inputs, outputs, review, verification, validation, transfer, changes, and the DHF holding the trail. Inputs are requirements. - The differe
您將下載的實際檔案範例。
// how to install
不到 2 分鐘
四個步驟。任何 AI 聊天。
- 01下載檔案
結帳後，下載連結會寄到您的收件匣。將檔案儲存至裝置上的任意位置。
- 02開啟你的 AI 聊天功能
Claude、ChatGPT、Gemini、Grok 或 Copilot - 無論你目前使用哪一個。
- 03貼上檔案內容
將其放入系統 prompt、專案指示或自訂指示欄位中。
- 04開始工作
您的 AI 現已設定為專業助手。您可以詢問它任何與其專業領域相關的問題。
不需要技術知識。不需訂閱。一次付費，永久使用。
// compatible with
支援所有主要的 AI 聊天服務。
將檔案放入您的 AI system prompt、專案指示或自訂指示中。無需設定。無需程式碼。不受供應商綁定。
// faq
關於此產品的問題
Which biomedical engineer skills does this file actually add?+
Design control structure under 21 CFR 820.30 and ISO 13485, DHF and DMR organisation, design input writing, verification and validation protocols with sample size rationale, risk management to ISO 14971, 510(k) and De Novo strategy, IEC 60601 and 62304 test mapping, ISO 10993 biological evaluation planning, and EU MDR technical documentation structure.
Will it give clinical or patient advice?+
No. It supports the engineer and the documentation, and it is written to refuse anything clinical. It will not interpret a patient result, suggest a treatment, advise on device use for a specific patient or write a clinical claim. Clinical evaluation, clinical claims and anything touching patient care belong to a qualified clinician and your clinical affairs team.
Can it write my 510(k) submission for me?+
It drafts sections and finds gaps. It has no access to your quality system, your test reports, your eSTAR or the FDA database, and it never claims to have searched one or filed anything. It will not invent a predicate K number, a standard clause or a test result. The submission goes out over the signature of your named regulatory affairs professional, who owns it.
Which AI tools does this skill work with?+
Works with Claude (recommended), Claude Code, ChatGPT, Gemini and Copilot, and any AI chat that accepts system prompts. Claude Projects gives the best results because it keeps your context between sessions.
Do I have to read it myself?+
No. The file is written for your AI to read, not for you. Upload it or paste it in once and the AI takes on the role. After that you just ask it questions the way you normally would. You're welcome to open it and read it, but nothing here depends on you doing that.
Is this a physical book?+
No, it's digital. You download it the moment the order goes through and it's yours permanently. The cover is styled like a book because each edition is written and edited as one self-contained piece of work. The reading part is your AI's job, not yours.
準備好讓您的 AI 專精了嗎？
一個即插即用的檔案。一次付費，永久保留 - 適用於 Claude 和 ChatGPT。
