• warning: realpath() [function.realpath]: SAFE MODE Restriction in effect. The script whose uid is 659 is not allowed to access /tmp owned by uid 0 in /home/xynergy/public_html/includes/file.inc on line 190.
  • warning: realpath() [function.realpath]: SAFE MODE Restriction in effect. The script whose uid is 659 is not allowed to access /tmp owned by uid 0 in /home/xynergy/public_html/includes/file.inc on line 190.

Medical Device Manufacturers

Industry Challenges

Medical industry conditions are forcing unprecedented pressure on profits due to a combination of issues:

  • Need to reduce risk of critical quality, health, and safety issues
  • 21 CFR Part 820 Quality System Regulation
  • 21 CFR Part 11 compliance
  • Environmental compliance regulations coming
  • Global product development coordination for supply chain readiness

 

XYNERGY for Medical Device Companies

XYNERGY's  Enterprise Solutions for Medical Device Manufacturing (localized for Hong Kong and China Business Environment) can help you : Help you reduce product risks, manage compliance to quality systems and environmental regulations, and achieve Lean product development. FMEA & APQP functionality streamlines compliance to FDA QSR regulations and supports the development of quality products to mitigate potential product risks. RoHS & WEEE functionality ensures environmental compliance to the coming international regulatory requirements. Ensure operational excellence in manufacturing and distribution.