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ISO 13485. Is it worth to the Medical Device Industry.

Posted 29th May 2015 at 09:33 AM by somashekar

While the ISO 13485 is the medical devices QMS - requirements for regulatory purposes., where are the CBís about regulatory purposes. Is it not the domain of the CB with competency built in its auditors to audit and report the applicable regulatory compliance...
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Am I unduly concerned ?

Posted 2nd February 2014 at 03:04 AM by Dr. L. Ramakrishnan

One of the safety issues that we normally check during audits / assessments is the electrical fittings in storage / handling areas for highly inflammable substances including petroleum based products (e.g. Petrol, aviation kerosene etc). We check if...
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Implementing an improvement program is like cooking!

Posted 16th January 2014 at 09:13 PM by lokeky1

Implementing an improvement program like Lean is like cooking. Cooking is easy (if taste doesnít matter).

First you decide what you want to eat. Get all the ingredients together then toss it about and out comes the food! In a rather similar...
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Making Quality and Compliance Invisible

Posted 24th August 2013 at 10:09 PM by PotentCompoundSafety

Several years ago I was at a conference that was discussing key design principles for mobile applications. Some of the key points that I recalled were as follows:
  • Design for one hand. You usually are doing something with a least one hand. Make
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Frontline Documentary - 'The Retirement Gamble'

Posted 25th April 2013 at 12:51 AM by Marc (Marc Smith's Basic Blog)

Frontline Documentary - 'The Retirement Gamble'

Some food for thought...
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