Regulatory Open Forum

Hi Regulateers,

Has/does anyone use Hazard Analysis and Critical Control Point (HACCP) in their device risk management process?  Do you use it for design, manufacturing, or both?  How well is it accepted by regulatory authorities/auditors?  What are the biggest benefits and challenges?  

Thanks in advance for sharing your experience,

Tina

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Aroa Biosurgery
Auckland
New Zealand
------------------------------

You might have better luck with this one at Elsmar Cove.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 19-Jul-2017 03:54
From: Tina O'Brien
Subject: HACCP

Hi Regulateers,

Has/does anyone use Hazard Analysis and Critical Control Point (HACCP) in their device risk management process?  Do you use it for design, manufacturing, or both?  How well is it accepted by regulatory authorities/auditors?  What are the biggest benefits and challenges?  

Thanks in advance for sharing your experience,

Tina

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Aroa Biosurgery
Auckland
New Zealand
------------------------------