| Zorich Technical Consulting & Publishing | ||||||||||||||||||||||||
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| Specializing in minimalist approaches to Quality Systems & Statistical Methods. Providing Quality System auditing services to ISO 13485 and ISO 9001, US GMP/QSR (21CFR820), Canada's CMDR/CMDCAS, and Europe's MDD+IVDD Publishers of simple powerful Statistical Spreadsheets, bare-bones fully-compliant Quality Systems, and HazMat65(tm) (Hazmat65 is a Proposition 65, a.k.a. "Prop 65" or "Prop65", software database). Offering formal training in quality systems, & seminars / workshops in statistical methods. |
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| Client List | ||||||||||||||||||||||||
| Quality Systems | ||||||||||||||||||||||||
| Statistics | ||||||||||||||||||||||||
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| Prop 65 | ||||||||||||||||||||||||
| Seminars | ||||||||||||||||||||||||
| If you would like to be pre-notified whenever we come to the SF Bay Area on other business, please send us a request ( JOHNZORICH@YAHOO.COM ) to add you to our notification mailing list (we do not give the list to anyone else, we don't use it for any other purpose, and we "blind copy" all recipients, so that no one sees to whom else the notification was sent). | ||||||||||||||||||||||||
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| Our Silicon Valley CA + Reno/Carson NV branches provide consulting, auditing, training, seminars / workshops, SOP's, and software to simply both compliance with government regulations, and use of statistics, in the areas of: • FDA/GMP/21CFR820, MDD/IVDD, & Canadian Medical Devices Regulations • Prop 65 (a.k.a., Proposition 65, Prop65) • Reliability Statistics, Statistical Process Control (SPC), and Gage R&R (both freeware and commercial statistical spreadsheet software is available on the "statistics" page of this website). We focus on medical device companies, especially start-ups, but also consult for non-medical and for multi-national corporations. We have many years medical device industry experience, including R&D, Manufacturing and Quality/Regulatory, and several years working part-time as a "Notified Body Auditor" to ISO 9001, ISO 13485, the Canadian MDR, and Europe's MDD / IVDD. |
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