Case Study – Transition to ISO 13485:2016

Penlon: Quality at its core.

Penlon's core business is the design, development and manufacture of anaesthesia equipment and other complementary life support products.

The organization is certified to ISO 13485:2016,ISO 13485:2003 under CMDCAS, and holds CE marking and FDA clearance for its medical devices as well as other global licenses required by market demands.

This case study follows their journey towards ISO 13485:2016 and includes client tips and insights.

Penlon: Quality at its core