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醫材沛方
從小在工廠長大的阿沛
33 episodes
1 week 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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EP27|從 IVDD 到 IVDR:為什麼歐盟審查變這麼「硬」?台灣企業該怎麼準備?
醫材沛方
31 minutes
1 month ago
EP27|從 IVDD 到 IVDR:為什麼歐盟審查變這麼「硬」?台灣企業該怎麼準備?

IVDR 大限將至,你的產品準備好了嗎?

歐盟正式從 IVDD → IVDR,讓全球體外診斷醫材廠全部重寫遊戲規則。
更嚴格的分類、更高的臨床證據要求、更多上市後監管(PMS/PMPF)……
到底這波改革,是挑戰還是台灣 IVD 廠的轉機?

本集《醫材沛方》邀請 BSI Business Development Manager 王韻涵 Aurora,
帶來第一線審查經驗與台灣企業最常卡住的地方,包括:


你將聽到:

  • IVDR vs. IVDD 到底差在哪?為什麼歐盟要全面升級?
  • 哪些 IVD 廠會被 IVDR 衝擊最大?哪些反而迎來機會?
  • 台灣業者最常忽略的準備工作(尤其是上市後監控與臨床證據)
  • 尚未進入歐盟的廠商,要不要現在準備?會不會延到後面再衝?
  • BSI 近期的審查案例:哪些企業做得好?哪些被卡關?
  • 選擇 BSI 的理由:Full Scope、審查深度與國際採認
  • BSI 如何協助廠商降低風險,加速拿證
  • 歐盟以外是否會跟進 IVDR?全球法規趨勢怎麼走?
  • 給台灣工廠的建議:
  • 第一個動作應該是什麼?
  • 什麼時候開始準備不會太晚?



如果你的產品包含試劑、儀器、POCT、快篩、感測、AI 輔助診斷——
這一集會讓你一次掌握 IVDR 的本質、方向與全球影響力。

歡迎收聽醫材沛方,追蹤我的Facebook、YouTube!

加入會員,支持節目: https://medicalpei.firstory.io/join
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