BryKor offers consulting services for ISO, AAMI and FDA regulations and guidance associated with medical devices, biologics and pharmaceuticals.

Primary consulting is provided by Trabue D. Bryans, with 35 years' experience in microbiological and associated testing surrounding regulations for the sterilization sciences.

Trabue Bryans CV 2-2012.pdf

• Sterilization validation (radiation, ethylene oxide, steam, dry heat)
• Radiation dose setting / substantiation /dose audits (Method 1, Method 2, VDmax)
• Reusable device reprocessing (cleaning efficacy, steam and EO re-sterilization)
• Sterility testing / methods development (USP, AAMI / ISO)
• Bioburden determination / methods development
• Microbial identification / evaluation
• Endotoxin / pyrogens
• Environmental monitoring

• 6-month agreements from 5 hours to 30 hours per month ($1K to $6K per month)
• Agreements include a one-day on-site visit at no charge (except for travel expenses)Hourly consulting ($250/hour, 2 hour minimum)
• On-site training / presentations ($1500 half day, $3000 full day)
• Regulatory audit assistance on site or by phone ($300/hour or $2000/day) 
• Document development / review / editing ($200/hour, 2 hour minimum)

Site is still under construction, so please be patient and visit again for updated information