Medical Devices for Plastic Surgery
Plastic surgery medical devices help patients in reclaiming both form and function after traumatic injuries, congenital deformities, or surgical interventions. These devices encompass a diverse range of technologies, each tailored to address specific reconstructive challenges with precision and efficacy.
From advanced implantable solutions that restore lost tissue volume and structural integrity, to cutting-edge biocompatible materials that promote tissue regeneration, plastic surgery medical devices are at the forefront of innovation.
With ongoing advancements in materials, design, and surgical techniques, these devices continue to evolve, and Eclevar can help bring this technology to patients around the world. Contact us for an early-start development of your device.
Eclevar has the power and knowledge to perform first class Clinical Trials
Eclevar Medtech specializes in designing customized clinical trials to match the unique requirements of your medical device. Our clinical team has extensive experience acquired from working with Notified Bodies, CROs, and sponsors/manufacturers. With more than 20 years of experience, we are able to provide manufacturers with all key aspects of a Clinical Trial:
- Team of capable professionals
- Site selection and management
- Data management
- Safety monitoring
- Regulatory compliance
- Documentation
- Audit preparation
- Medical writing
Pre- and post-market studies
Our proficiency covers comprehensive services for both pre-market and post-market studies, spanning across class I to class III devices. Eclevar understands the intricacies of operational and financial hurdles associated with medical device clinical trials and aims to simplify the pathway for market entering.
Clinical Trial Development for Plastic Surgery Medical Device
We work alongside your team, ensuring that all necessary documentation is meticulously crafted to meet the stringent requirements set by regulatory agencies. With Eclevar by your side, you’ll find a trusted partner, equipped to guide you through the development of your Clinical Trial Protocol.
Our trial development plan follows the ICH Good Clinical Practice guidelines:
- Study design
- Selection and exclusion of subjects
- Treatment of subjects
- Assessment of efficacy
- Assessment of safety
- Adverse events
- Statistics
- Quality control and assurance
- Ethics
- Data handling and recordkeeping
Contact us to explore our comprehensive services and embark on a journey of successful Clinical Trial execution.
Eclevar is by your side throughout the entire lifecycle of your device
Pre-Market Clinical Trial
Our experienced medical staff and experts in clinical research are here to assist you throughout the entire process of planning, overseeing, and assessing clinical trials for market approval at different jurisdictions. Get in touch with our team to learn how our solutions can be instrumental for you during this critical phase.
Post-Market Data Collection
Our PMCF Data Collection activities helps manufacturers gain valuable insights into the real-world use of their products and make informed decisions to enhance patient safety and product effectiveness.
Work with Eclevar Medtech for Plastic Surgery Medical Devices
Global market access
We provide a customizable market access approach in both global and local markets. As an international organization, trusted and recognized around the world, Eclevar can support clinical trials in EU, UK, Australia and Japan.
EDC, ePRO technology and e-consent for faster and better study management
This patient-centric approach of ePROs offers a unique and valuable perspective that enhances the accuracy and authenticity of clinical outcome assessments. Learn more about the benefits of ePRO for Clinical Trials.
Experience
Our experience not only ensures the meticulous development and innovation of medical devices but also contributes to the assurance of safety, efficacy, and adherence to regulatory standards, ultimately upholding the industry’s commitment to advancing healthcare technologies.
