ISO9000 Product and Process Development

Edical May provides product and process quality documentation that is based on GMP and FDA-auditable practices.  The effective use of product and process development tools like design of experiments (DOE) and process capability (Cpk) requires timely and accurate dimensional feedback. From the planning and design phases, through execution, measurement and corrective action, the Edical May team provides comprehensive quality engineering solutions.

Above: New Inspection Lab with CMM Technology

A partial list of possible quality documentation deliverables follows:

• Part submission warrant,

• Certificates of analysis,

• Appearance approval report,

• Failure mode and effects analysis,

• Process flow diagram,

• Control plan,

• 100% Dimensional layout,

• Process capability study, and

• Gage R&R study.

In addition, Edical May helps companies navigate the FDA and clinical trails process.  To learn more about this, click here.