Regulatory & Quality Solutions LLC provides full-service regulatory affairs and quality assurance expertise to medical device organizations. Our mission is to navigate the complex regulatory landscape and determine the most efficient paths to a safe and effective product, cleared for U.S. and international marketing. This is accomplished through results-driven, experienced team members providing you with on-site leadership and support in all areas of regulatory affairs and quality assurance. Our services focus on the following:
- Regulatory: Regulatory strategies, FDA 510(k)s, EU Technical Files/Design Dossiers and worldwide registrations. Includes regulatory standards requirements assessment.
- Regulatory Officer Retention: Regulatory Officer to provide guidance to management teams regarding day-to-day regulatory risks and business-balanced decision making.
- Program/Project Management: Advising, guiding and executing on all aspects of a company’s regulatory, quality and clinical programs, including, but not limited to, product development and testing, quality systems procedures, clinical trials and FDA submissions.
- Quality System: ISO 13485:2003 and FDA QSR compliant quality system development and training, manufacturing registrations, device listings, and quality system auditing.
- Clinical Research Organization: Providing advice, guidance and execution in navigating the clinical trials process from beginning to end, including, but not limited to alignment with the FDA on product claims, and clinical trial management and monitoring. Experienced leadership with international network of investigators. Completes clinical evaluations in support of the 2007 amendment to Medical Device directive 93/42/EEC (effective March 2010) for devices marketed in the European Union.
- Product Quality: Predictable product quality through development of processes for supplier qualifications, supplier quality inspections, part and tool qualifications, and capability analyses.
- Safety Risk Management: Risk management process development to ISO 14971 standard & implementation for new products. Product FMEA and risk assessment leadership and support.
- Verification and Validation: Verification and Validation process and tools development, planning and test protocol generation. Successful usability studies to meet FDA 510(k) requirements and EU Medical Device Directive requirements.
- Design Assurance: In addition to risk management and V&V, design assurance includes development of product requirements and design history file documentation, and guidance through product development issues.
- Acquisition Integration Leadership: Acquisition assessments of regulatory and quality aspects as well as integration planning and completion of all regulatory and quality areas.
- Post-Launch Regulatory Support: Development of post-market surveillance processes and ongoing support of associated activities including field safety risk assessments, field corrections, recalls, supplier assessments and FDA inspection preparation and guidance.
- Venture Capitalist Due Diligence: Assessments of medical device companies from the perspective of regulatory, quality system, product safety, product quality, clinical strategy, reimbursement, and other industry-specific processes.
Regulatory and Quality Solutions LLC Service Offerings
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