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.
Dallas / Ft. Worth, Texas. However, more than half of our clients are in Silicon Valley CA (we are frequently in the SF Bay Area for work).
We 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
• Reliability Statistics, Statistical Process Control (SPC), Normality Testing,
Gage R&R, power calculations, sample size estimations, and so on.
(commercial statistical spreadsheet software, as well as some freeware,
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 ).