Rick Rutherford is a retired U. S. FDA Investigator & medical device expert with 24 years of domestic & international experience performing regulatory inspections in the US & Overseas (120+ in 22 countries). These included Pre-Market Approvals & 510(k) applications for Class II & Class III medical device submissions & Post-market surveillance & for-cause compliance inspections enforcing 21 CFR Part 820 Quality System Regulation, Part 211 and Parts 50 & 56. He has performed inspections across the full spectrum of the Agency’s jurisdiction–primarily in the medical device arena, but also biologics & finished & active pharmaceutical inspections. He excels in culturally sensitive employee interactions. ??His extensive experience covers auditing in many areas of regulated industries including sterile operations, lyophilization, implantable devices, IVD, instrumentation, latex operations, EO & radiation sterilization, V & V activities, CNC operations, design control, quality system documentation, contract manufacturing, & combination products, drug manufacturing & biologics.

During his career with the U.S. Food and Drug Administration, his greatest achievement was convincing regulated industry to excel and move toward compliance without Agency regulatory actions. However, his work resulted in Warning Letters, import alerts and detentions without examination, and input toward national consent decrees. Since leaving the Agency, he has started a consultancy primarily in the medical device arena and performed FDA mock audits, provided training, provided guidance to firm for FDA 483 and Warning Letters responses to the Agency, worked on consent decree certifications to the Agency and baseline audits.