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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
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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?

510(k) Regulations. Is there room for improvement? Sure...But Don’t Throw the Baby Out With the Bath Water

by Jack Dhuwalia
Jack Dhuwalia
Jack is an expert trouble-shooter specializing in the medical industry. He has b
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on Friday, 08 February 2013
Regulatory Compliance 2 Comments

510k_productsThe recent Institute of Medicine (I of M) report brings an old idiom to life: “Don’t throw the Baby out with the Bath Water!” According to the IOM, “...The current process is untenable.”  I applaud that Dr. Jeff Shuren, Director, CDRH, FDA, has announced his support for the current 510(k) regulations to demonstrate “substantial equivalence” to a device on the market.

Effective Design Control

by Jack Dhuwalia
Jack Dhuwalia
Jack is an expert trouble-shooter specializing in the medical industry. He has b
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on Thursday, 15 November 2012
Product Development 0 Comments

design_control_transition JD Consulting helped to develop a design control system that not only helped the client with their product development process, but also passed FDA inspection.

FDA Town Hall Meeting in San Francisco, September 2011

by Jack Dhuwalia
Jack Dhuwalia
Jack is an expert trouble-shooter specializing in the medical industry. He has b
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on Tuesday, 16 August 2011
510(k) Regulation 2 Comments

Jack is working on preparing for the next town hall meeting in San Francisco in September with Dr. Shuren and other FDA people. Any comments or input for this meeting would be appreciated. Just add to this post, or send an email to This e-mail address is being protected from spambots. You need JavaScript enabled to view it.

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