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