WALT BRITTLE
Summary of Achievements
- Thirty-five years of experience in regulatory compliance, manufacturing, research and development, and clinical practice. Competency in contract sterilization, single-use device reprocessing, sterility assurance products, endoscopes, surgical drapes, medical textiles, biological products, hospital supplies, specialized medical electronic devices, complex diagnostic systems, optics, laser systems, surgical instruments, microsurgery, and fiber optics.
- Written, reviewed, and approved numerous 510(k) applications over a 30-year period.
- Led numerous mock regulatory inspections, reviewed 483 responses, and installed numerous complete quality management systems in the past 10 years.
- Extensive knowledge of medical devices and device sterilization gained while working at V.
Mueller-AHSC, Narco/Pilling, Synthes, Meadox Medicals, Surgicot, and Steris.
- More than 20 years of experience in medical device general management, with hands-on leadership of product development (design controls), marketing, regulatory affairs, and manufacturing operations in seven different companies.
- Performed internal and external QMS and GMP audits, both domestic and international, over 10 years.
- Six years' experience troubleshooting sterilization cycle failures in hospitals, including one extensive ethylene oxide sterilization cycle failure investigation covering three years of device
history sterilization records to identify and recommend corrective and preventive actions.
- Fourteen-month warning letter remediation for a prescription drug packaging firm supervising
a team of three consultants.
Who we are
