Device and Combination Products
In the rapidly evolving field of medical technology, developing and bringing device and combination products to market requires specialized expertise and strategic support. At Safevigilance, we provide comprehensive services tailored to the unique challenges of developing medical devices, combination products, and drug-device combinations. Our expert team is dedicated to helping you navigate regulatory pathways, ensure product safety and efficacy, and achieve successful market entry.
1. Device Development and Design
Support the entire lifecycle of medical device development with our comprehensive services:
- ● Concept Development: Assist with the development and refinement of device concepts to meet clinical and user needs.
- ● Design and Prototyping: Design and create prototypes, including iterative testing and modifications to optimize functionality and usability.
- ● Engineering and Testing: Conduct engineering and performance testing to ensure your device meets regulatory and performance standards.
2. Combination Product Development
Navigate the complexities of combination product development with our expert support:
- ● Formulation and Integration: Develop and integrate drug and device components to create effective combination products.
- ● Preclinical and Clinical Testing: Design and execute preclinical and clinical studies to evaluate the safety, efficacy, and performance of combination products.
- ● Regulatory Strategy: Develop regulatory strategies specific to combination products, addressing both drug and device requirements.
3. Regulatory Affairs and Compliance
Ensure compliance with global regulatory requirements with our regulatory affairs support:
● Regulatory Pathways: Develop tailored regulatory strategies for medical devices and combination products, including FDA, EMA, and other global agencies.
● Submission Preparation: Prepare and manage regulatory submissions, such as 510(k) premarket notifications, PMAs, CE Mark applications, and Combination Product Applications (CPAs).
● Regulatory Liaison: Act as a liaison with regulatory authorities to facilitate communication and address any regulatory inquiries or issues.
4. Quality Assurance and Control
Maintain the highest standards of quality with our quality assurance and control services:
- ● GMP and GxP Compliance: Ensure compliance with Good Manufacturing Practices (GMP) and Good Clinical Practices (GxP) throughout the product lifecycle.
- ● Quality Management Systems: Implement and maintain quality management systems to monitor and ensure product quality and regulatory compliance.
- ● Risk Management: Conduct risk assessments and implement risk management strategies to address potential issues throughout development and production.
5. Clinical Trials and Testing
Design and manage clinical trials and testing for medical devices and combination products:
- ● Clinical Trial Design: Develop protocols and design clinical trials to evaluate the safety, efficacy, and performance of your products.
- ● Site Management: Identify, qualify, and manage clinical trial sites to ensure high-quality data collection and participant safety.
- ● Data Management: Oversee data collection, analysis, and reporting to support regulatory submissions and product development.
6. Post-Market Surveillance and Support
Ensure ongoing success and compliance with post-market surveillance and support:
- ● Post-Market Studies: Conduct post-market studies to gather real-world data and assess long-term product performance and safety.
- ● Adverse Event Reporting: Implement systems for monitoring and reporting adverse events and safety signals.
- ● Market Access and Support: Develop strategies for market access, including pricing, reimbursement, and distribution planning.