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醫材沛方
從小在工廠長大的阿沛
25 episodes
6 days ago

《醫材沛方:醫療器材產業秘辛大聲說》

你對醫療器材的世界感到好奇嗎?本節目由主持人阿沛,深入訪談來自醫材圈的專家與實戰玩家,從行銷策略、國際法規到市場實務,揭開產業的神祕面紗。無論你是醫材新鮮人、創業者,還是想了解產業趨勢的投資人,這裡都有你想知道的第一手觀點!

本節目由騏峰公司贊助播出,帶你用最貼近實務的方式,聽懂醫療器材的大小事。

Medical Secrets Exposed: Pei’s Inside Look into the Medical Device Industry

Are you curious about what really happens behind the scenes in the medical device world? Host Pei dives into real conversations with experts in marketing, regulations, and global markets. This podcast makes complex industry topics easy to understand, from product development to go-to-market strategies.

Whether you're new to the field, a healthcare entrepreneur, or an investor seeking insights, this show is your gateway to the inner workings of the medtech world.

Sponsored by Chi Feng Co., Ltd., helping you uncover the real stories behind medical innovation.

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All content for 醫材沛方 is the property of 從小在工廠長大的阿沛 and is served directly from their servers with no modification, redirects, or rehosting. The podcast is not affiliated with or endorsed by Podjoint in any way.

《醫材沛方:醫療器材產業秘辛大聲說》

你對醫療器材的世界感到好奇嗎?本節目由主持人阿沛,深入訪談來自醫材圈的專家與實戰玩家,從行銷策略、國際法規到市場實務,揭開產業的神祕面紗。無論你是醫材新鮮人、創業者,還是想了解產業趨勢的投資人,這裡都有你想知道的第一手觀點!

本節目由騏峰公司贊助播出,帶你用最貼近實務的方式,聽懂醫療器材的大小事。

Medical Secrets Exposed: Pei’s Inside Look into the Medical Device Industry

Are you curious about what really happens behind the scenes in the medical device world? Host Pei dives into real conversations with experts in marketing, regulations, and global markets. This podcast makes complex industry topics easy to understand, from product development to go-to-market strategies.

Whether you're new to the field, a healthcare entrepreneur, or an investor seeking insights, this show is your gateway to the inner workings of the medtech world.

Sponsored by Chi Feng Co., Ltd., helping you uncover the real stories behind medical innovation.

Powered by Firstory Hosting

Show more...
Medicine
Education,
Business,
Society & Culture,
Management,
Marketing,
Entrepreneurship,
How To,
Health & Fitness,
Documentary
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EP13|法規不只是門檻:談醫材取證、ISO 10993 與市場策略 feat. 亮宇生物科技總經理 高志豪 Howard Kao
醫材沛方
21 minutes
3 months ago
EP13|法規不只是門檻:談醫材取證、ISO 10993 與市場策略 feat. 亮宇生物科技總經理 高志豪 Howard Kao

在醫療器材的世界裡,創新讓產品誕生,但法規才能決定它能不能走向世界。

本集《醫材沛方》邀請到 亮宇生技總經理 高志豪(Howard Kao),帶我們深入解密醫材取證的真實挑戰與策略,從 ISO 10993 生物相容性法規 到 CE、FDA 510(k)、TFDA 等國內外驗證差異,全面剖析法規背後的邏輯與市場影響。

你將聽到:

  • 為什麼醫材廠常卡在法規驗證這一關?
  • 國內外 ISO 10993 審查差異:邏輯 vs. 測試結果
  • 材料揭露、製程透明化、上市後追蹤——最新法規趨勢
  • 如何避開驗證過程的高風險陷阱?
  • 取證成本為什麼飆升?二類、三類醫材的現實數字
  • 亮宇的實務輔導特色:從規劃、評估到溝通協調,一站式助攻取證


Howard 不只是談法規,更用「市場為終點」的觀點,幫助醫材製造商在滿足合規的同時,也能落地執行、成功出海。

🎙 如果你正走在醫材開發、取證或國際市場拓展的路上,這一集會讓你少走很多冤枉路。

歡迎追蹤主持人阿沛Facebook、醫材沛方Yotube頻道!

加入會員,支持節目: https://open.firstory.me/user/cmau0hqva123601wsd8e3fxqy
留言告訴我你對這一集的想法: https://open.firstory.me/user/cmau0hqva123601wsd8e3fxqy/comments



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醫材沛方

《醫材沛方:醫療器材產業秘辛大聲說》

你對醫療器材的世界感到好奇嗎?本節目由主持人阿沛,深入訪談來自醫材圈的專家與實戰玩家,從行銷策略、國際法規到市場實務,揭開產業的神祕面紗。無論你是醫材新鮮人、創業者,還是想了解產業趨勢的投資人,這裡都有你想知道的第一手觀點!

本節目由騏峰公司贊助播出,帶你用最貼近實務的方式,聽懂醫療器材的大小事。

Medical Secrets Exposed: Pei’s Inside Look into the Medical Device Industry

Are you curious about what really happens behind the scenes in the medical device world? Host Pei dives into real conversations with experts in marketing, regulations, and global markets. This podcast makes complex industry topics easy to understand, from product development to go-to-market strategies.

Whether you're new to the field, a healthcare entrepreneur, or an investor seeking insights, this show is your gateway to the inner workings of the medtech world.

Sponsored by Chi Feng Co., Ltd., helping you uncover the real stories behind medical innovation.

Powered by Firstory Hosting