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Comparative Analyses

ÌìÃÀ´«Ã½ 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.

Design Assessment

With 30 years of experience on a diverse range of products, ÌìÃÀ´«Ã½ can help you make the best design decisions to ensure the optimal performance and safety of your product.

Risk Analysis and Mitigation

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

Strategic Test Plans and Regulatory Pathway

ÌìÃÀ´«Ã½’s experts will provide thorough test strategies that align with your regulatory goals.

Pre-clinical Evaluations

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 Medical Device Regulations (MDR) and can author full CERs and literature reports.

Project Management

The regulatory landscape can be difficult to navigate, ÌìÃÀ´«Ã½ offers support to manage your pathway to market from design support through clearance/approval.

FDA Submissions and Reports

Our regulatory team will provide the highest quality FDA submissions. Element 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
• Pre-Submissions / Q-submissions
• Investigational Device Exemption (IDE)
• Humanitarian Device Exemption (HDE)
• Emergency Use Authorization (EUA)
• Breakthrough device designation
• Safer Technologies Program (STeP)
• De Novos

Deficiency Response Strategies and Support

Receiving an FDA deficiency notice and the way you respond is critical to obtaining clearance and addressing FDA concerns. Using our collaborative approach, ÌìÃÀ´«Ã½ can help facilitate conversations and leverage our established brand to work through the deficiencies.