Regulatory Affairs

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. 

• Defining the Indication-for-Use in alignment with the go-to-market strategy and product value proposition 

• Identifying device classification and regulatory pathways 

• 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 technical documents, risk assessment and requirements traceability

• 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.