4.4 Regulations

Dicom Explorer is a CE marked device

Dicom Explorer is registered with the UK Medicines & Healthcare Products Regulatory Agency (MHRA) as a:

Class 1 Medical Device under Council Directive 93/42/EC

Declaration of Conformity

As such only users licensed and trained by Pukka-J Ltd are authorised to use the software for diagnostic purposes.

Vigilance

Pukka-J Limited operates a vigilance system in accordance with the EC Guidelines:

2.12 Medical Devices Vigilance System

It is important that users report any any incident which led, or might have led, to one of the following outcomes:

• In the unlikely event of a fatality of a patient.
• In the unlikely event of serious injury of a patient, user or other person.

Reports should be made in writing within 48 hours of the incident occurring:

Click on the following link for an 'incident report form - it will open a word document. Fill in the report, save to disk and email as an attachment to: vigilance@pukka-j.com or fax to +44(0) 1380 860066.

Click for incident report form

We would suggest you also save a copy of your report details on your hard drive or as a hard copy.