JD Consulting Blog

Updates from Jack Dhuwalia

Blog entries categorized under Risk Management

Risk Management

2 posts in this category

Jack Dhuwalia Is The Invited Presenter At ASQ Orange Empire Chapter Monthly Meeting On February 11th

by Jack Dhuwalia
Jack Dhuwalia
Jack is an expert trouble-shooter specializing in the medical industry. He has b
User is currently offline
on Thursday, 06 February 2014
Risk Management 1 Comment

Jack Dhuwalia is pleased to announce that he is an invited presenter at the local ASQ Chapter’s Monthly Meeting on February 11, 2014. The Topic is: Risk Management – ISO 14971:2012.

“EN ISO 14971:2012 - Application of Risk Management to Medical Devices”

Register Now  

The ASQ 0701 Clinic on EN ISO 14971:2012 - Application of Risk Management to Medical Devices will be held at Double Tree in Santa Ana on February 11 evening.

The program will be interactive discussing components of the standard, learning the significant changes, understanding key annexes and when/how to apply them. Risk Management is an integral part of product design, development, manufacturing and use. Medical Devices are no exception.  Regulatory bodies such as FDA expect a formal process to manage and document these activities.

EN ISO 14971 – Risk Management: ALERT

by Jack Dhuwalia
Jack Dhuwalia
Jack is an expert trouble-shooter specializing in the medical industry. He has b
User is currently offline
on Tuesday, 07 May 2013
Risk Management 1 Comment

risk_womanThe revised EN ISO standard is effective now – it is past the “grace period!” Risk Management has now become a serious business!  Please do not take it lightly; The time is now!  

The EN ISO 14971:2012 Medical Devices Application of Risk Management to Medical Devices was published in July, 2012 and became effective on 10/30/2012 … simultaneously as the preceding 2007-2009 standard was discontinued.  This was a rather brief notice to allow those in the industry to get prepared.  Wonder if this is a preview of things to come … who knows?

Primary Operating Areas

Learn More About Us