Medical devices

Clinical Affairs

We provide specialized clinical support for medical device companies to ensure your clinical trials meet regulatory standards and deliver reliable results.
Clinical Evaluation Reports: Preparing detailed reports that evaluate the clinical performance and safety of medical devices.
Clinical Trial Management: Managing medical device clinical trials with a focus on compliance and data integrity.
Clinical Data Management: Ensuring secure and accurate handling of data from medical device trials.
Clinical Operations: Overseeing day-to-day operations of clinical trials to ensure efficiency and adherence to protocols.
Clinical Project Management: Coordinating clinical projects to meet timelines, budgets, and regulatory standards.

Our regulatory affairs team helps medical device companies deal with the regulatory environment, from development to the market.
Technical Documentation Remediation: Updating and correcting technical documentation to meet evolving regulatory standards.
FDA Submissions: Preparing comprehensive documents for FDA approval of clinical trials.
International Submissions: Managing submissions to international regulatory bodies to ensure global compliance.
Regulatory Strategy: Developing strategies to successfully navigate the complex regulatory landscape for medical devices.
Lifecycle Management: Overseeing the regulatory lifecycle of medical devices, from development to post-market.

Viltis assists medical device companies in ensuring ongoing compliance and safety in the post-market phase.
Audit Readiness: Preparing for and managing audits by regulatory bodies to ensure compliance.
Complaint Handling and Reporting: Efficiently managing and reporting complaints related to medical devices.
Field Safety Corrective Actions (FSCA): Implementing corrective actions for safety issues identified in the field to maintain compliance and safety.