Articles

Effective Writing Sets you Apart in the Health Care Field

 

Dangerous Documents How Good Writing Can Help Medtech Firms Avoid Painful Litigation

Dangerous Documents: How Good Writing Can Help Medtech Firms Avoid Painful Litigation

 
Quality Pointer
 How can quality professionals get on management’s good side?”
Don’t Be Haunted By Your Words

Don’t Be Haunted By Your Words. (Advice to FDA and industry officials on how to write complete and accurate documents.)

 

How to Not Get Sued

 

 

Mastering the Clinical Investigation

Mastering the Clinical Investigation,” published in MD&DI Online. OEMs can benefit from the latest resources and current practices for clinical investigation programs.

 

 

How Companies Can Avoid Writing Dangerous DocumentsI wrote an article, “How Companies Can Avoid Writing Dangerous Documents,” that was published in RAJ Devices.

 

See what else the press had to say about Dangerous Documents

 

Design Controls Are They Worth the EffortDavid Jones, the quality assurance director in the Regulatory Affairs and Philips Business Excellence division of Philips Consumer Healthcare Solutions and I were interviewed by Erik Swain of MD&DI on “Design Controls: Are They Worth the Effort?” in MD&DI Magazine.

 

 

Assessing the Cost of Poor QualityDan Olivier of Certified Compliance Solutions and I wrote an article on”Assessing the Cost of Poor Quality” for MD&DI Magazine.

 

 

Freedom of Information Act RequestsMarlene Bobka and I wrote an article, “Freedom of Information Act Requests: A Primer” for MD&DI Magazine.

 

 

Empowering the Quality and Regulatory Compliance Functions
Glenn George of QRC Associates, Ken Imler of Arrow International and I wrote on “Empowering the Quality and Regulatory Compliance Functions” for MD&DI Magazine.

 

 

Corrections and Removals To Tell or Not to Tell FDAFran Akelewicz and I have an article on “Corrections and Removals: To Tell or Not to Tell” in  MD&DI Magazine.

 

 

 

Optimizing Regulatory Compliance Nine Strategies for SuccessRichard DeRisio and I wrote an article “Optimizing Regulatory Compliance: Nine Strategies for Success” for MD&DI Magazine.

 

 

 

FDA Industry Partnerships Moving toward More Equitable EnforcementFDA/Industry Partnerships: Moving toward More Equitable Enforcement,” published in  MD&DI Magazine.