Medical Device Development

Your medical device CRO partner

For medical devices, good engineering does not necessarily guarantee clinical or commercial success. At times, regulators and device manufacturers seem to be on opposing sides of the playing field. Regulators often contend with pressure to fast-track approvals while at the same time ensuring product safety and efficacy. On the other hand, manufacturers risk spending time and resources to develop a device, only to not receive approval to go to market.

Executing a successful market entry strategy involves navigating the regulatory approval process, designing and conducting efficient clinical trials, and adeptly evaluating the existing marketplace.

Whether it is augmenting internal staff with a functional outsourcing approach, or managing your entire medical device development program from beginning to end, we can do it, and do it more efficiently.

• Biostatistics
• Clinical Monitoring
• Data Management
• Global Study Feasibility
• Medical Affairs & Monitoring
• Patient Recruitment
• Safety Surveillance
• Project Management
• Regulatory & Strategic Consultancy
• Regulatory Submissions & Filings
• Site Selection & Management
• TEMPO eClinical Platform

Clinipace medical device experts provide the following advisory and operational services:

Keys to navigating regulatory pathways

• Premarket Notification 510(k) and Premarket Approval
• Investigational device exemption
• Importance of seeking feedback

Keys to an running an efficient clinical development program

• Be design intelligent
• Protocol considerations
• Use of technology
• Run a transparent, efficient study
• Establishing clinical efficacy