Andrews-Cooper has extensive experience complying with a wide variety of process standards and regulations including ISO 9001 and for medical devices: 21 CFR Part 820, ISO 13485 and ISO 14971.
A-C offers the flexibility to work within our clients’ Quality Management System. For medical device development, this approach makes it easier to deliver documents and records into our clients’ Design History File, Device Master Record and vaulting system.
Alternatively we can perform development within our own QMS. The Andrews-Cooper QMS complies with ISO 9001 for the development of commercial products and manufacturing automation systems. It complies with ISO 13485 for the development of medical devices. Our QMS also incorporates best practices from the following sources:
- Capability Maturity Model Integration (CMMI) from Carnegie Mellon University’s (CMU) Software Engineering Institute (SEI).
- The Project Management Body of Knowledge (PMBOK) from the Project Management Institute (PMI).
- Good Automated Manufacturing Practices (GAMP-5) from the International Society for Pharmaceutical Engineering (ISPE).
- Applicable process standards from the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) including ISO 14971 for Safety Risk Management, IEC 60601-1-8 for Alarms, and IEC 62304 for Software Development.