FAQ
We’re here to provide clarity and insight on quality management consulting. Explore our frequently asked questions to find the answers you need regarding compliance and quality systems.
Your Questions Answered
What is FDA Compliance?
FDA compliance refers to adhering to regulations set by the U.S. Food and Drug Administration, ensuring that products are safe and effective. Compliance is essential for medical device manufacturers aiming to enter or maintain a presence in the U.S. market.
Why is ISO 13485 Important?
ISO 13485 is crucial for organizations involved in the design and manufacturing of medical devices. It establishes requirements for a quality management system that demonstrates the organization's ability to provide medical devices that consistently meet customer and regulatory requirements.
How Can Total Quality Solutions Assist?
Total Quality Solutions specializes in helping companies implement effective quality management systems. Our expertise in FDA regulations and ISO standards allows us to guide organizations through compliance, audits, and system enhancements tailored to their specific needs.
What Types of Organizations Do You Work With?
We collaborate with a range of organizations, from startups to well-established medical device manufacturers and service providers. Our tailored consulting services cater to various operational needs, ensuring that every client achieves their compliance objectives effectively.