High quality, customized regulatory solutions for medical device and pharmaceutical companies

KP Medical Device Consulting LLC is a boutique consulting firm composed exclusively of senior-level professionals with former U.S. FDA reviewer/auditor and GLP test laboratory experience. Our consultants each offer decades of experience to provide comprehensive support across the biological safety, regulatory, quality, and clinical domains for medical devices, pharmaceuticals, and combination products. Our unique approach blends deep technical knowledge with regulatory and compliance insight, enabling clients to make informed decisions grounded in both science and regulatory strategy.

We understand that every product and every company faces distinct challenges. That's why we deliver customized solutions—not one-size-fits-all templates. Our team works closely with clients to evaluate their specific needs, whether it's developing biocompatibility and toxicology testing plans, managing microbiology and sterilization programs, or resolving regulatory agency deficiencies. We have the technical and regulatory expertise required to help our clients navigate complex challenges efficiently and strategically.

Our service offerings span the full product lifecycle, from early development through post-market compliance:

• Regulatory Strategy & Submissions: U.S. FDA pre-market submissions, EU technical documentation, deficiency resolution, and strategy for complex regulatory challenges.
• Technical Expertise: Biocompatibility, toxicology, microbiology, sterilization, reprocessing, packaging, and shelf-life evaluations.
• Risk Analysis & Mitigation: Customized testing plans and method design, test failure mitigation, and biological/toxicological risk assessments.
• Quality: Audits and inspection readiness, QMS implementation, compliance remediation, QA/RA oversight.
• Clinical: Clinical evaluation, technical/medical writing, literature review, and post-market documentation.

See our full list of consulting services for Biological Safety and Regulatory, Quality and Clinical.