{"product_id":"manasi-biomedical-engineer-assistant","title":"Manasi - Biomedical Engineer Assistant AI Skill","description":"\u003cp\u003eThe design history file has a hole where the design inputs should be, and the auditor will find it before you do. Device programmes rarely fail on engineering. They fail on the record of it. This file gives your assistant the biomedical engineer skills that regulated development actually runs on: design controls, predicate strategy, verification kept separate from validation, and a risk file written while the design was still moving.\u003c\/p\u003e\u003cp\u003eIt asks the device class, the intended use statement and the target market first, because a US Class II 510(k) and an EU MDR technical file are different projects with different evidence. Then it works in submission language: indications for use rather than marketing claims, essential performance under IEC 60601-1, software safety class under IEC 62304 with SOUP declared, biological evaluation planned under ISO 10993-1 instead of a reflex cytotoxicity test, and risk controls traced from hazard to the verification that closes them.\u003c\/p\u003e\u003cp\u003eOne file, one payment, no subscription. Loads into Claude, ChatGPT or Gemini in about two minutes.\u003c\/p\u003e","brand":"KissMySkills","offers":[{"title":"Default Title","offer_id":58636814680328,"sku":null,"price":29.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1036\/1444\/7880\/files\/manasi-biomedical-engineer-assistant-1.png?v=1789396411","url":"https:\/\/kissmyskills.com\/it\/products\/manasi-biomedical-engineer-assistant","provider":"KissMySkills","version":"1.0","type":"link"}