Beaufort Advisors helps you develop, implement and maintain the systems, processes and documentation required to comply with the numerous regulations and standards that apply to your medical products. We have extensive experience with FDA regulations, European and Canadian directives and regulations, and ISO standards.

Whether taking a new product to market or maintaining the quality of existing products, we can help you understand the regulatory requirements, develop your quality management systems and conduct comprehensive assessments to protect and secure the viability of your products.

Quality Assurance Services
»	Quality system design and implementation
»	Quality system audits—both internal and supplier—to applicable regulations and standards (e.g., QSR/cGMP, cGLP, cGTP, cGCP, ISO 9001, ISO 13485, etc.)
»	Development and implementation of standard operating procedures
»	Development and implementation of complaint handling systems
»	Development of Corrective and Preventive Action (CAPA) programs
»	Process and equipment validation, including design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ)
»	FDA / Third-Party audit support, including mock inspections
»	FDA 483 and Warning Letter action plans and responses
»	Software and system validation and verification (21 CFR Part 11 compliance)
»	Comprehensive quality system training

To discuss how Beaufort Advisors can help you achieve your clinical research and regulatory compliance objectives, please contact us at info@beaufortadvisors.com or call 757.383.6000 .