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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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EP26|ISO 13485不是文件,是信任的語言:醫材品質管理體系的現在與未來
醫材沛方
27 minutes
2 months ago
EP26|ISO 13485不是文件,是信任的語言:醫材品質管理體系的現在與未來

很多人以為 ISO 13485 只是張認證書,但對國際買主與法規單位來說,它其實是一種「被信任的能力」。本集邀請 BSI 英國標準協會 Business Development Manager 王韻涵(Aurora),從第一線審查與企業實務出發,拆解台灣導入現況、EN 與非 EN 的選擇、各國 QMS 差異與常見盲點。
如果你是 OEM/ODM、新創或準備出海歐美市場的醫材廠,這一集會幫你把「證書」轉化成「競爭力」。
你會聽到:

  • 台灣普及度與迷思:為何 CE/FDA 不能取代 ISO 13485?
  • EN vs. ISO 版如何選?什麼情況只要 ISO、何時一定要 EN?
  • TFDA QMS 與 13485 的關係:國際標準 + 在地差異怎麼補?
  • 美國 QSR → QMSR、歐盟 MDR/IVDR 對台廠的實際影響
  • OEM 最常卡關:設計開發文件、供應商稽核、風險管理整合(ISO 14971)
  • 為何國際買家在攤位上看到 BSI 證書就更願意談?

一句話總結:
ISO 13485 不是通關密語,而是你讓世界相信你的方法論。

歡迎追蹤主持人阿沛Facebook、醫材沛方Yotube頻道!

免費追蹤,更新資訊不漏接: https://open.firstory.me/join/cmau0hqva123601wsd8e3fxqy
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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