We’re committed to measuring, managing and improving both process and product. Regulatory compliance is an obvious priority in the medical device industry. After all, the products we’re making can have real and lasting effects on people’s lives. At PLS, we implement state of the art quality systems management standards and practices to proactively manage the process of manufacturing your product at every stage of development and production. Which results in improving the ultimate quality of the delivered product.
To ensure FDA and international compliance, we maintain certification for ISO 13485 – medical devices (quality management systems), and audit for compliance to both ISO 14971 – application of risk management to medical devices and USA 21 CFR Part 820 – Quality System Regulation. We are also FDA registered as a contract manufacturer.
We maintain critical quality controls and ensure good manufacturing practices (GMP) compliance along the way with:
- periodic internal audits
- development and/or remediation of DHFs (design history files), technical files and DMRs (device master records)
- USA FDA 510(k) development and submission
- CE mark development and audit preparation
- inventory, purchasing and receiving ERP solutions
At Prospect, we believe it’s equally important to focus on both process and product. Because quality and compliance aren’t mutually exclusive.