Quality Assurance
At Dr. Respira Care Pvt. Ltd, quality is not merely a process—it is our core philosophy. We maintain an uncompromising commitment to excellence throughout the entire product lifecycle, from design and development to production and post-market surveillance. Our robust Quality Management System is meticulously aligned with global regulatory requirements including ISO 13485, FDA 21 CFR Part 820, GMP, CE and other applicable standards.
Every device we manufacture undergoes rigorous verification and validation protocols to ensure clinical safety, efficacy, and reliability. Through continuous monitoring, risk assessment, and data-driven process improvements, we strive to exceed the highest benchmarks of quality and performance. Our quality assurance framework is engineered to foster innovation without compromising compliance, delivering trust to healthcare professionals and better outcomes for patients worldwide.
Quality Policy
We, at Dr. Respira Care Pvt. Ltd. are dedicated to consistently delivering safe, effective, and high-quality medical devices that meet or exceed customer expectations and regulatory requirements. Our mission is rooted in a culture of quality, guided by integrity, transparency, and a commitment to continuous improvement.
We pledge to:
- Comply fully with all applicable regulatory and statutory requirements
- Maintain an agile and proactive quality system
- Empower our team through training and accountability
- Drive innovation while ensuring patient safety and product reliability
- Foster a quality-first mindset across all levels of the organization.
Our quality policy is not just a statement—it’s a promise to every stakeholder who entrusts us with advancing healthcare through cutting-edge medical technology.