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Able Medical Devices Achieves ISO 13485:2016 Certification

Able Medical Devices, a Gwinn, Michigan-based contract manufacturer of implants and instruments, has received ISO 13485:2016 Certification.

“We achieved this certification very quickly due to our experienced team,” said Eric Baldwin, Vice President and General Manager.“Able Medical earns our customers’ trust every day and expects to be their most reliable partner. This milestone is another step that allows us to accomplish that goal.”

In addition to manufacturing, Able’s capabilities include:

  • Product development
  • Prototyping
  • Packaging
  • Design compliance
  • Process development/validation
  • Regulatory affairs
  • Testing, metrology

Source: Able Medical Devices