医療機器産業参入セミナー

医療機器産業への参入を目指している企業や、大学発のベンチャー企業など、これから医療機器を製造販売しようと計画している企業は多く存在する。
しかしながら、医療機器は有効性・安全性・品質の確保が法令および規制要件で要求されており、またそれら要求事項は複雑かつ難解である。
異業種から医療機器産業へ参入したが、開発が思うように進まず、申請資料が作成できない、承認(認証)が受けられないといった事例も多くみられる。
これは、医療現場を知らない、医療機器規制を知らない、産業機械の開発経験はあるが治療・診断装置を開発した経験がないなど様々な理由による。
医療機器には何らかのリスクが潜んでおり、安全性を担保することは極めて重要である。 リスクはどのように回避・低減するべきだろうか。また医療機器の設計管理では何に留意するべきだろうか。

本セミナーでは、これまで多くの医療機器企業の設立を支援してきたコンサルタントが、規制要件の観点から医療機器産業への参入の方法をわかりやすく解説する。

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