医疗仪器规管服务

比较分析

im体育APP utilizes a proprietary methodology to help streamline non-clinical testing and support all marketing applications. The proprietary methodology combined with our extensive biomechanical and physiological knowledge has been successfully implemented for over 10 years.

设计评估

With 30 years of experience on a diverse range of products, im体育APP can help you make the best design decisions to ensure the optimal performance and safety of your product.

风险分析和降低

Our experts will help you perform a comprehensive risk assessment and create mitigation activities to ensure regulatory success.

Strategic Test Plans and Regulatory Pathway

im体育APP’s experts will provide thorough test strategies that align with your regulatory goals.

临床前评估

Our regulatory and consulting team can provide regulatory and pre-clinical testing strategies to outline all the testing needed to support your goals.

Clinical Evaluation Reports (CERs)

Our regulatory team is well-versed in the 医疗设备 Regulations (MDR) and can author full CERs and literature reports.

项目管理

The regulatory landscape can be difficult to navigate, im体育APP offers support to manage your pathway to market from design support through clearance/approval.

FDA提交的文件和报告

Our regulatory team will provide the highest quality FDA submissions. im体育APP has experience with some of the most complex submissions and will ensure you are receiving the best support throughout the regulatory submission process. Our submission support includes but is not limited to:

• 510(k)s
• 预提交/预提交
• Investigational Device Exemption (IDE)
• Humanitarian Device Exemption (HDE)
• 紧急使用授权(EUA)
• 突破性装置名称
• 安全技术计划(STeP)
• De novo

Deficiency Response Strategies and Support

Receiving an FDA deficiency notice and the way you respond is critical to obtaining clearance and addressing FDA concerns. 使用我们的合作方式, im体育APP can help facilitate conversations and leverage our established brand to work through the deficiencies.