“In my twenty years of Class III medical device experience, I have not had the pleasure of working with a Chinese regulatory firm as talented and knowledgeable.
As CFDA is increasing their technical and clinical review, it is one of the few companies staffed to assist medical device companies in this area. Their focus and dedicated support has exceeded out expectation. In my search for a strategic partner in China, they exceeded the other companies in all areas. While they have a very experienced Regulatory and Marketing team, their technical engineering, clinical, and international project management expertise place them above other companies in this area.”
Vice-President,Global Regulatory/Clinical Affairs Implantable Device |
“在我過去20年的三類醫療器械從業經驗中,并未找到令人滿意的中國法務咨詢公司。由于CFDA不斷提高技術和臨床審查要求,貝迪諾恩是少數幾個能提供專業咨詢的公司之一。貝迪諾恩的從業專注度及客戶支持度超出我們的預期。在我尋找中國戰略合作伙伴的過程中,發現他們具備經驗豐富的注冊和市場團隊,擁有技術、臨床和國際項目管理的專業知識及經驗,他們完全超越該領域的其他公司?!?/em>
國際植入醫療器械生產商 副總裁,國際注冊/臨床事務部 |