Clinical Investigation Plan Design

In medical device development, misalignment between design and regulatory requirements often leads to additional studies or delayed approvals. For you as a medical device manufacturer, clinical investigation plan design sets the foundation for both evidence generation and regulatory review.

How Apices supports clinical investigation plan design

Apices supports you in designing medical device clinical investigation plans that align with applicable medical device regulations and real-world clinical execution. We work with you at an early stage to translate your device claims and intended use into a study design that can be implemented in practice.

Design activities consider clinical objectives, patient population, endpoints, and operational feasibility. Regulatory requirements and notified body expectations are factored into the design from the start, rather than addressed after the study is underway.

Clinical investigation plan design at Apices is informed by hands-on experience with clinical studies in regulated environments. Design decisions are reviewed in the context of site capabilities, study conduct, and data collection requirements.

Alignment with regulatory and operational execution

Clinical investigation plan design is closely aligned with regulatory and ethics submissions, clinical operations, and data management. This integrated approach helps ensure that the investigation can be approved, executed, and reported without disconnects between design intent and operational reality.

You benefit from early visibility into how design choices affect timelines, site selection, and data requirements. Where alternatives exist, Apices helps you understand the implications so you can make informed decisions.

Regulatory framework considered

Clinical investigation plan design is developed in alignment with applicable regulatory frameworks. In the European Union, this includes Regulation (EU) 2017/745 on medical devices (MDR), relevant MDCG guidance, ISO 14155 for good clinical practice in medical device investigations, and national competent authority and ethics committee requirements. Where applicable, U.S. requirements under FDA regulations, including 21 CFR Parts 812 (Investigational Device Exemptions) and 820, are also considered to support global development and regulatory strategies.

What you can expect from this service

You can expect a clinical investigation plan design that supports both regulatory compliance and practical execution. The outcome is a study design that is aligned with device regulations and can be delivered by sites without unnecessary complexity.

Clinical investigation plan design at Apices is designed for medical device sponsors who want clarity, alignment, and execution reliability from the start.