Practical Compliance Results, LLC

Are you ready for your next FDA inspection or Notified Body audit⁉️ As a former FDA Investigator with 30-years of industry expertise, I prepare my medical device and IVD clients to be ready for their next FDA inspection and Notified Body audit in the areas of compliance, quality assurance, and quality systems. ⭐️ 30 years of experience in the creation, maintenance, remediation, and auditing of quality system and technical documentation for sterile and non-sterile medical devices and in vitro diagnostics (IVD) to ensure compliance with domestic and international quality and regulatory requirements. ⭐️ Support my clients by providing expertise in building, training, leading, and motivating high-functioning quality and regulatory compliance teams ensuring lasting knowledge transfer and inspection readiness. ⭐️ Talented internal and supplier auditor having practical experience with FDA inspection techniques, Quality System Regulation (QSR), and on-site inspection procedures. ⭐️ Proficient in European and Global quality system standards such as ISO 13485, ISO 14971, ISO 9001, and the EU Medical Device Regulations (MD/AIMD, IVD) and associated Technical Documentation. ⭐️ Work extensively with contract design and manufacturing organizations (CDMO) to ensure that product is designed and manufactured in compliance with client, US, and international quality system requirements. ⭐️ FDA-483, Warning Letter, and Consent Decree responses and overall compliance. Areas of Expertise: FDA Regulations / QSR ISO 13485 Quality Management Systems FDA Inspection Procedures Quality System Inspection Technique (QSIT) Quality Assurance Quality Systems Quality Control Quality Planning Regulatory Compliance Change Control Culture Change FDA Readiness and Remediation Recall / Field Action Complaint Handling Internal, Supplier, Third Party Audits Inspection and Testing Process Control Control of Nonconforming Product Corrective Action (CA) Preventive Action (PA)