Quality System


MDI’s quality system is certified to

  • ISO Standard 13485:2016
  • CFR 21 ¶ 820 Code of Federal Regulations Medical
  • Anvisa Resolution RDC No.16:2013 Brazilian Medical Device Regulation Requirements

MDI’s inspection lab excels in meeting all customer quality requirements; from receipt of raw material through final inspection of finished goods, your customer satisfaction is guaranteed. Our lab offers Optical/Video Inspection capability as well as CMM Contact Inspection with use of MCOSMOS software.

  • Medical Devices ISO 13485:2016 NSAI Certified logo Mitutoyo Crysta Apex 574 CMM
  • MCOSMOS CAD Inspection Software
  • RAM Optical Vision Systems
  • Deltronic 16” Optical Comparators
  • Visual Microscope Inspection
  • Keyence IM-6225 Image Dimension Measuring System
  • Mitutoyo SJ400 Profilometer
  • Micrometers, Calipers, Gage Pins, Gage Blocks, Concentricity Gages, Microscopes, Granite Surface Plates, Digital Indicators, Hardness Tester

Certificates and Non-Disclosure

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