We TRACC Global are your go to medical device solution.Our commitment to excellence extends beyond product development. Collaboration is at the core of our ethos.
TRACC Global covers the entire spectrum of medical device development and commercialization. From concept development and regulatory strategy to quality management systems implementation, production, risk management, post-market surveillance and vigilance, we provide guidance and support at every stage of the product lifecycle. Our goal is to streamline processes, minimize risks, and maximize efficiency to help our clients bring safe, effective, and compliant medical devices to market.
Our team possesses in-depth knowledge of the Indian regulatory framework for medical devices. We stay up to date with the latest regulations, guidelines, and compliance requirements, enabling us to provide accurate and timely advice to our clients.
We uphold the highest standards of professionalism and ethics in all our interactions. Our team operates with integrity, maintaining confidentiality, and ensuring compliance with regulatory and legal requirements. Clients can trust us to handle their regulatory affairs with the utmost professionalism and transparency.
We strive to develop a deep understanding of our clients' vision, goals, and objectives. By aligning our expertise with their vision, we provide regulatory solutions that drive their success in the Indian market. Our commitment to high-quality standards ensures that clients receive top-notch service and support throughout their regulatory journey.
At TRACC Global, we provide our clients with valuable insights and analysis across industry sectors. Our team conducts thorough market research, keeping clients informed about market trends, competitive landscape, and regulatory updates. These insights empower our clients to make informed decisions and stay ahead of the curve.
If you are in need of expert guidance and support in navigating the intricacies of medical device regulations, TRACC Global invites you to explore our range of consultancy services.
Post-market surveillance of medical devices refers to the ongoing monitoring and evaluation of medical devices after they have been approved or cleared for marketing and made available to the public. It is an essential component of ensuring the safety, performance, and effectiveness of medical devices throughout their lifecycle.
TRACC Global Offers the following Services1. Adverse Event Reporting : TRACC Global shall provide guidance on the proper collection, analysis, and reporting of adverse events associated with medical devices. We can assist in setting up robust adverse event reporting systems, training personnel, and ensuring compliance with reporting obligations.
2. Vigilance : TRACC Global shall help develop vigilance systems and risk management processes tailored to specific medical devices. This includes establishing procedures for monitoring device performance, analyzing data, detecting trends, and taking appropriate actions to manage risks and ensure patient safety.
3. Post-Market Surveillance Studies: TRACC Global shall assist in designing and conducting post-market surveillance studies to assess the safety and effectiveness of medical devices in real-world settings. We support our client with study design, data collection and analysis, and reporting of study findings.
TRACC Global envisions a future where medical device companies have seamless access to expert guidance and support throughout the product development lifecycle. Our aim is to empower our clients to bring safe, effective, and innovative medical devices to market, ultimately improving patient care and outcomes. In pursuit of our vision, we are committed to
Excellence: strive for excellence in regulatory affairs, quality assurance, clinical evaluations, risk management, and market access.
Innovation: stay at the forefront of technological advancements, industry trends to help our clients harness the full potential of their innovative ideas.
Collaboration: collaborating with our clients, we ensure a deep understanding of their goals and challenges, allowing us to provide tailored solutions and achieve shared success. Integrity: We uphold the highest standards of integrity, ethics, and professionalism in all our interactions.
Global Impact: strive to make a meaningful impact on a global scale. Together, let's shape the future of healthcare through excellence, collaboration, and impactful solutions
Our mission encompasses the following key principles
Expert Guidance: strive to be a trusted source of expert guidance and support for our clients. Regulatory Compliance: By ensuring compliance, we help our clients mitigate risks, streamline their operations, and establish a solid foundation for product development and commercialization.
Innovation Enablement: We believe in the power of innovation to transform healthcare. Our mission is to enable our clients to harness innovation and bring their groundbreaking medical device concepts to fruition
Client-Centric Approach: client’s success is at the core of our mission. We prioritize understanding their unique needs, challenges, and goals. Through close collaboration and personalized attention, we develop solutions that address their specific requirements and optimize their business outcomes. We aim to build lasting relationships based on trust, transparency, and exceptional customer service.
Ethical Conduct: uphold the highest standards of integrity, professionalism, and ethical conduct Through our mission, we aim to empower our clients, drive industry innovation, and contribute to the advancement of healthcare globally. By delivering exceptional consultancy services, we strive to make a tangible and positive impact on the lives of patients and the healthcare community as a whole.