SERVICES · QUALITY SYSTEM DEVELOPMENT

 

Quality System Development

 

For start-ups, contract manufacturers and established companies remediating or transitioning

 

ISO 13485 systems built, rebuilt or right-sized, with FDA QMSR, EU MDR and MDSAP mapped onto one set of procedures your team can run.

 

Staged to the product

The system grows as the device matures. Design controls and risk management first; production, complaint and surveillance processes when the product actually needs them.

 

Every engagement works toward the same three outcomes: Safe. Effective. Available. To talk through your project, schedule a 30-minute call from the Contact page.