| Consulting
Services for the Medical Device Industry |
| REGULATORY
SERVICES |
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Regulations, protocols and approvals weighing you down? Let us lift the weight off you (don't worry ... we'll leave the pressure on the Chief of Staph). We can save you money! Isn't this what a consulting company is supposed to do? Biotesting, device design/evaluation, the FDA approval process are grounded in science ... not guesswork! Failure to understand the underlying chemical, mechanical, biological and physiological systems leads to improperly designed tests, problematic device design and other nuisances, causing long and frustrating delays in the regulatory approval process. The result is costly product redesigns and, ultimately, costly delays in product release! NOTE: To review our consulting plans and how we work, please go to the "Consulting" page. |
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We can | |
 | Lead you through the FDA regulatory process to get your devices approved with Combination Devices our specialty |
| Help you develop properly directed IDE’s, including guiding you through institutional HRB's |
| Organize your clinical trials for IDE, 510(K) or PMA approval |
| Organize or even establish your biocompatibility testing program in compliance with both FDA and ISO |
| Properly classify your device and, if you need it, perform both the full FDA approval process as well as the biocompatibility testing regimen |
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| Evaluate your current device design and application and recommend practical changes in design and materials selection to improve both function and market appeal - a function we have performed literally hundreds of times |
| Establish specifications for your device for both FDA compliance and to fulfill customer requirements |
| Review your product and processes and solve problems relating to bioburdens and/or pyrogens |
| Solve your high purity water system problems or design the appropriate system to meet both your needs and FDA requirements |
Remember: Even a one-month delay in a product release can cost 10's of thousands of dollars through lost sales, lost market edge, frustrated customers!
And you can trust the work from the only person in the entire world to have brought an antiseptic medical device through from start to finish - and by myself! See the details under "A few examples of successes over the years" on the Engineering page.
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© 2003 Consulting Services for the Medical Device Industry
