Picture1
USA
CE
Can

Prospect Life Sciences is committed to providing high quality products and services to our Clients.

We are certified to ISO 13485:2016 by an international conformity assessment body. Download our certificate here.

Our certification can streamline your auditing when you select us as your medical device developer and/or manufacturer.  We can serve as your quality system until you establish your own or we can help manage and strengthen your existing quality system.

  • Applied Quality System regulations and standards:
    • ISO 13485 (Medical devices - Quality management systems)
    • ISO 14971 (Application of risk management to medical devices)
    • ISO 14155 (Clinical investigation of medical devices for human subjects)
    • USA 21 CFR 820 (FDA Quality System Regulation)
    • Europe 93/42/EEC (MDD - Medical Device Directive)
    • Canada SOR/98-282 (Medical Devices Regulations)
  • Periodic Internal Audits
  • Development or remediation of Design History Files, Technical Files, and Device Master Records
  • USA FDA 510k development and submission
  • CE mark development and audit preparation