Allan Kimble

• Conducts material characterization and stability studies for combination medical devices to establish scientifically supported expiry dating in compliance with FDA and ISO 10993 requirements.
• Prepare technical summaries, validation protocols, and regulatory documentation for submission under FDA 21 CFR 820 and ISO 13485 frameworks.
• Serve as internal Subject Matter Expert (SME) in materials science, sterilization compatibility, and process validation across global manufacturing sites.
• Collaborate with design assurance and regulatory affairs to ensure alignment between analytical data, risk assessments, and product labeling.

• Established and managed a consulting firm with a focus on material science for medical devices.
• Provides brokering services for laboratory testing.
• Subject matter expert on topics including but not limited to biocompatibility, material science, cleaning process validation, material compatibility with sterilization, endotoxin analysis and mitigation, protein assays, and analytical chemistry.
• Serving clients in North America, Europe, and Asia Pacific regions.

• Led R&D and design control activities supporting chemical and biological cleanliness for orthopedic and surgical device portfolios under ISO 13485 and EU MDR requirements.
• Developed digital database enabling virtual assessment of material–sterilization compatibility, reducing qualification cycle time by 20% and supporting regulatory submissions.
• Acted as global SME for product stewardship, ensuring compliance with REACH, ECHA, EPA, and MDR, while driving phase-out of restricted substances (BPA, phthalates, PFAS).
• Designed and validated cleaning and sterilization processes using FDA guidance and ASTM standards to mitigate contamination and biocompatibility risks.
• Authored and reviewed technical reports, design history files (DHF), and risk management files for global regulatory submissions and notified body audits.
• Conducted experimental studies on endotoxin detection, deactivation, and particulate contamination; presented findings at the 2022 Kilmer Conference (Athens, Greece).
• Developed and delivered global training programs for 100+ engineers and scientists to strengthen ISO 10993 and chemical cleanliness knowledge base.

Undergraduate work in medical device materials (coatings, BioGlas), analytical instrumentation (spectroscopy and chromatography)