| Zorich Technical Consulting & Publishing | ||||||||||||||||||||||
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| Specializing in minimalist approaches to Quality Systems & Statistical Methods. 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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| Quality Systems | ||||||||||||||||||||||
| 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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