DESIGN CONTROL FOR MEDICAL DEVICE

The medical device industry encompasses a wide range of technologies and applications, ranging from:

  • simple hand tools to complex computer-controlled surgical machines,
  • from implantable screws to artificial organs,
  • from blood-glucose test strips to diagnostic imaging systems and laboratory test equipment.

These devices are manufactured by companies varying in size and structure, methods of design and development, and methods of management.

Design Controls need to be implemented from the early development stage. 

A proper design control process will not only assure compliance to FDA CFR 21 820.30  but also provide a tool and framework to develop a succesful and well performing device.

We have huge experience in medical device field drafting design controls process and documentation for new device development or remediating existing Design History Files (DHF) to fill compliance gaps. Our experience in medical devices includes:

– Orthopaedics and Osteosynthesis device

– Device incorporating software

– Endoscopic device

– Diagnostic devices

– Active devices

GET SUPPORT / CLARIFY YOUR DOUBTS

Reach out to us for advice, questions or support about implementation of design control for development of new medical device product  or remediation of existing DHF and design control process to improve compliance and efficiency.

Write to info@dhf-experts.com or fill out the form.