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The Insight Report

mdi’s staff is constantly encountering issues, situations and problems that are not only unique to our clients but to the manufacturing industry as a whole.  When we see such an issue, and we feel it can provide some help for other companies, we will prepare an INSIGHT REPORT and publish it on this Web Site.

If you have any comments on these INSIGHTS we want you let us hear them. If you have any of your own INSIGHTS that you feel would be of value to other companies, we would be pleased to hear from you and to discuss them with you and if you allow, we would even put them up on this site for others to learn from.

After viewing an INSIGHT REPORT, use the CLOSE WINDOW link at the bottom of each issue to return to the website. 

CURRENT ISSUE: Volume 10  Number 2 Chapter and Verse on SOP's - November 2008

Insight Volume 10: 2007 Year Issues

• 2007 - MDI Visits Nicaragua – June 17 – 21
• 2007 – New FDA oversight to take place – Democrats Rule – Now What?

Insight Volume 9: 2006 Year Issues

• Boston Scientific Corporation – Market Savvy but Compliance Deficient!

Insight Volume 8: 2005 Year Issues

• Will compliance to ISO-13485 assure you that you will also meet the Canadian Standards? Don’t bet on it!
• Plan B – Victim to a Politicized FDA - We Hope Not!
• FDA Inspection of Clinical Trial Sites
• 'Combination Products' - Part Two
• 'Combination Products' - Part One
• The 510(k) - an asset that can be sold and transferred
• FDA Affidavits -  YOU NEVER SIGN !!!
• The FDA - A Tale of Two Inspections

Insight Volume 7: 2004 Year Issues

• Are you as bad as the FDA483 appears to say you are?
• How the FDA is Causing Monopolies

Insight Volume 6: 2003 Year Issues

• The FDA Can Not Be Your Consultant!
• Finding the Right Consultant for dealing with an FDA Injunction
• What is the difference between ISO 9000:1994 and ISO 9000:2000?
• Maybe you should be careful about what you wish for?

Insight Volume 5: 2002 Year Issues

• The FDA can be Petitioned and...  You do have a say in the REGULATIONS that affect you.
• The turtle that wins the race…. Or, The slow moving FDA gets the final say
  CAPA: Corrective Action - Preventive Action…  aren’t they really the same
• The Olympus Recall: A lesson to be learned
• ISO9001:2000 Quality Management Systems
• Complying with the IVD Directive
• Warning Letters Review
• Closing Gaps in Our Post-market Safety Net for Medical Devices
• Risk Management: Hazard Analysis and FMEA

Insight Volume 4:  2001 Year Issues

• Design Requirements and Design Specifications
• Outsourcing - China
• What the FDA wants to Know about your Recalled Product.
• Know your Preamble? Or, better yet, KNOW YOUR PREAMBLE!! 
• Problems Encountered with Equipment Validation Software - Part 2
• Problems Encountered with Process Validations - Part 1
• FDA's Civil Money Penalty Policy - The Guidance on Reduction of Civil Money Penalties for Small Entities
• The new FDA Compliance Program for the Inspection of Medical Device Manufacturers and what it means to you
• The New Year - Keeping “arrogance” at BAY
   

Insight Archives

• The 1998 - 2000 newsletters

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