今すぐサポートが必要ですか? 弊社は現在、新型コロナウイルスによる新しい課題に取り組むために、世界中のクライアントと協力しています。何かお手伝いできることはありますか? 詳細はこちら >

July 22, 2021 Regulatory Affairs

The Human Factor - Preparing Your Device for Usability Testing

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July 21, 2021 Life Science Consulting

Innovation and Rapid Growth: A Double-Edged Sword

With the breakthrough innovations we’re seeing in modern medicine, companies are facing…

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July 19, 2021 Life Science Consulting

FDA Guidance on Gene Therapy Products: RCR Testing and Monitoring...

Part four in our recent blog series related to FDA’s guidance document…

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July 15, 2021 Life Science Consulting

How to Ensure Your Workforce is GMP Compliant

Can you deliver what the Inspector expects? Ensure your team is GMP-ready…

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July 15, 2021 Life Science Consulting

Fundamentals of Data Integrity for ATMP Development

Advanced Therapy Medicinal Products (ATMPs) have the incredible potential to cure devastating…

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July 12, 2021 Regulatory Affairs

Pedaling While Fixing a Flat: Conducting a Good FDA Meeting...

Before using a significant risk medical device in a clinical study, Sponsors…

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July 1, 2021 Company News

Former Deputy Director of Diagnostics, Bill and Melinda Gates Foundation,...

Dr. Giachetti’s extensive experience managing complex diagnostics programs make her a valuable…

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June 28, 2021 Regulatory Affairs

45 Years of 510(k) Submissions: FDA Celebrates with Improvements to...

FDA is working to bring life-saving devices to market as quickly as…

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June 22, 2021 Regulatory Affairs

Understanding Cybersecurity Threats to Medical Devices

In this post, we talk about medical device cybersecurity, FDA's pre-market and…

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