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, Worldwide registration, and regulatory standards requirements assessment.
- Regulatory Officer Retention: Regulatory Officer to provide guidance to management teams regarding day-to-day regulatory decisions and regulatory risks.
- Quality System: ISO 13485:2003 and FDA QSR compliant quality system development and training, manufacturing registrations, device listings, and quality system auditing.
- Clinical: Clinical evaluations compliant with the European Union Medical Device Directive and MEDDEV 2.7.1 Guidance, as well as clinical trial support.
- Usability: Proven usability methodology that not only meets medical device regulatory requirements detailed in IEC 62366:2007, but also provides valuable customer feedback regarding product issues and effectiveness.
- Safety Risk Management: Risk management process development to ISO 14971 standard & implementation for new products. Early-stage safety risk assessment for new VC funded products.
- Product Quality: Predictable product quality through development of processes for supplier qualifications, supplier quality inspections, process validations, and capability analyses.
- Verification and Validation: Verification and Validation processes and tools development, planning and test protocol generation.
- Post-Launch Regulatory Support: Warning Letter / Consent Decree Remediation, leadership and support. Development of post-market surveillance processes and on-going 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, and other industry-specific processes.
Regulatory and Quality Solutions LLC Service Offerings
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