At Shaily, we believe in upholding the highest standards of quality. Our Quality Management System is ISO 13485 certified, complying with:

  • FDA CFR 21 part 820 Quality System Regulation & cGMP
  • MDD 93/42 EEC Medical Device Directive

Our QMS employs a mix of time tested and cutting-edge techniques to ensure adherence to quality standards, while optimizing operational efficiencies. These techniques include:

  • Six Sigma
  • Continuous Improvement Initiatives
  • Root Cause Analysis & CAPA
  • DFMEA & PFMEA
  • Process Capability Monitoring, through the use of Statistical Process Control methods
  • Use of CMM and custom fixtures for in-process quality control

Being ISO 13485 certified, Shaily satisfies all requirements for its customers to obtain a CE mark.

about medical plastics

Regulatory Compliance

 

We have experience in DMF fillings and also have the necessary knowledge and capability to support our customers in NDA and 510K registrations.