MCRA can help you create a quality system or modify your existing quality system to meet the requirements found in the QSR.
Services We Offer
- Perform validations from planning through completion (process, software, design, cleaning, sterilization, packaging)
- Assist with the implementation of lean manufacturing improvement system
- Process mapping and improvement
Our Integrated Approach
The law requires “manufacturers” and those holding/owning the 510k to implement a quality system that meets QSR requirements found in 21 CFR Part 820. MCRA can help you create a quality system or modify your existing quality system to meet the requirements found in the QSR. Additionally, we have operations experts that can help you save money in your manufacturing process by optimizing your manufacturing efficiencies.