Quality Documents


The Quality Management System at Planer Plc has been accredited to ISO13485:2003 (Medical devices. Quality management systems. Requirements for regulatory purposes).

Scope:

Design, Manufacture, Installation, Service and Repair of Controlled Rate Freezers, Incubators. Monitoring Systems and associated accessories for medical applications.  Sale of Cryogenic Systems and equipment.

All Planer manufactured Medical Devices have assessed against the Medical Device Directive (93/42/EEC) and have been CE Marked accordingly.

The CE Certificate can be found below along with the ISO13485 certificate and the Planer Quality Policy.

ISO 13485