Regulatory Affairs: Demonstrating Safety & Effectiveness

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Regulatory strategy sets the direction for all scientific, engineering, testing, and clinical work required to build a safe and effective medical device. However, we have seen challenges not only in regulatory compliance but also in its frequent misalignment with go-to-market strategy: 

• Indication for use is defined without considering the product's core value proposition, leading to commercialization delays and unnecessary regulatory burdens.

• Clinical work is conducted without considering reimbursement requirements, resulting in products that gain clearance or approval but still face commercialization barriers. 

• Prototyping is either underdeveloped or overdeveloped due to a lack of a clear data collection strategy, leading to go-to-market delays or budget overruns. 

At Eliomedica, we take a holistic approach to regulatory strategy by integrating engineering, testing, and go-to-market planning. This ensures the creation of targeted and sufficient safety and effectiveness data, aligning regulatory and business goals from the start.

We address the siloed approach that many startups take toward regulatory strategy by ensuring alignment with go-to-market, development, clinical, and fundraising efforts. Our approach covers key pillars:

Regulatory Strategy 

• Defining the Indication-for-Use in alignment with the go-to-market strategy and product value proposition 
• Identifying device classification and regulatory pathways 

Safety & Effectiveness Data

• Roadmapping for performance data collection from bench testing and pre-clinical to clinical
• Designing animal and clinical studies to generate safety and effectiveness data
• Creating Design History Files (DHF), risk assessment and requirements traceability

Regulatory Communications

• Engaging with the FDA through pre-submissions for early feedback
• Preparing for and submitting full regulatory applications (e.g., 510(k), De Novo, PMA), including technical documentation
• Leading communications with the FDA and coordinating follow-up and responses to FDA questions post-submission

We are technology enabled, leveraging Nyquist AI global intelligence platform with clinical, regulatory and medical device data.