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Prospect Life Sciences

Prepare to Prosper

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Quality Management

Quality Systems Management

With state of the art QS management standards and practices, Prospect ensures GMP and ISO compliance of your product at every stage of development and production.

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 patients’ 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. 

ISO 13485:2016
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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.

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