As a consultancy service provider for In Vitro Diagnostic (IVD) products, our primary goal is to assist you in navigating the complex regulatory landscape and ensuring that your IVD products meet the highest quality and safety standards. Our team of experienced professionals will work closely with you to provide strategic guidance, technical expertise, and support throughout the entire product development process.
Our services include:
- 1. Regulatory consultation: We help you understand the regulatory requirements for IVD products across different markets, such as the FDA in the United States, the European Union's In Vitro Diagnostic Medical Devices Regulation (IVDR), and other international authorities.
- 2. Quality management system (QMS) implementation: We support you in the establishment and maintenance of a robust QMS, which is essential for compliance with regulatory requirements and the successful commercialization of your IVD products.
- 3. Clinical validation and performance evaluation: Our team of experts will help you design and execute appropriate clinical studies to generate the necessary data to support regulatory submissions and product claims.
- 4. Risk management: We assist you in identifying, assessing, and mitigating potential risks associated with your IVD products, ensuring that they meet the highest safety standards.
- 5. Technical documentation: We provide support in preparing comprehensive technical documentation and submitting regulatory applications to various authorities.
- 6. Post-market surveillance and vigilance: We help you monitor your IVD products once they enter the market, ensuring continued compliance with regulatory requirements and addressing any potential safety concerns.
Our consultancy service is committed to helping you bring your IVD products to market in a timely and compliant manner, allowing you to focus on advancing healthcare and improving patient outcomes. We look forward to partnering with you on this journey.
