Clinical Strategy for Medical Devices
A good clinical strategy gives you a competitive advantage, by bringing your device to market faster and supporting unique claims with solid clinical evidence. The Clinical Evaluation is a critical element in the CE marking pathway for a new medical device on the European market. As a Regulatory and Clinical Consultant, our clinical strategy support can help to ensure that your medical device proposed Clinical Plan will be sufficient to meet the requirements.
Bring your device faster to the market
We will always take into account the feasibility of operational plans on a budget, timelines, and marketing requirements. A good Clinical Strategy gives you a competitive advantage, by bringing your device faster to the market and supporting unique claims with clinical evidence.
Sufficient Clinical Evidence
You are in the development of your medical device and need evidence to support the Clinical Performance and safety of your device. Compliance to (product) standards, verification testing, literature and clinical studies can contribute. In a Clinical Strategy, we will consider together with you how to gather the necessary evidence.
Product development phases
Your Clinical Strategy develops together with your device during the distinct phases of product development as design decisions might influence both risk management and claims. Qserve provided clinical strategies for all kinds of devices from Class I to Class III, at start-ups companies and multinationals. Regardless of the position of your company and device, we are able to help you with your strategy.
Qserve's experts are very familiar with medical device development processes and are able to identify the correct regulatory requirements to be addressed and develop the appropriate research question(s). A good clinical strategy gives you a competitive advantage, by bringing your device to market faster and supporting unique claims with solid clinical evidence.
A professional clinical strategy meets the following requirements:
- Identifies the specific regulatory requirements to be addressed
- Connects to the risk management activities/plan
- Relates to the clinical claims
- Verifies the need to collect (additional) clinical data
- Addresses the relevant clinical research questions.