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Quality

VistaMed’s primary strategy is to achieve total customer satisfaction by supplying defect-free products on time – every time. We have an unrelenting commitment to quality and apply those principles rigidly throughout all our business processes.

Quality at VistaMed

VistaMed is committed to working with our clients to achieve their quality objectives.

The team at VistaMed can assist with all the Quality and Regulatory requirements of your product/project, including:

  • Design History File & Review
  • Regulatory requirements of your product
  • First Article Inspections / PPAP
  • Product / Process Validations
  • Process Capability Studies
  • Gauge R&R
  • Biocompatability testing
  • Age / Shelf-Life testing
  • Performance Testing
  • Sterilisation Validation
  • Clinical Review (Literature and/or Clinical Trials)
  • Technical File
  • CE / 510K / PMA Submissions
  • ISO 13485 Certification
  • ISO 14644 Class 7 and 8 Cleanrooms
  • FDA Registered Manufacturing Sites – Registration Number : 3008328690
  • REACH Compliance
  • RoHS Compliance
  • cGMP Compliant
  • MDD 93/42 Compliant