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SERVICES

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OUR SERVICES

At Pinnacle, we offer a comprehensive range of consulting services designed to meet the specific needs of medical device companies. Our expertise ensures your products comply with regulatory requirements while maintaining the highest quality standards.

FDA Regulatory Consulting

  • Navigating FDA regulations

  • Premarket submissions (510(k), PMA, De Novo)

  • Regulatory strategy and planning

  • Post-market surveillance and reporting

  • Quality Assurance

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Quality Management System Development And Implementation

  • Internal and supplier audits

  • Risk management and mitigation

  • Quality Management System remediation

  • Lean Six Sigma

Process Improvement

  • Waste reduction

  • Efficiency optimization

  • Lean Six Sigma training and certification

  • Corrective and Preventive Actions (CAPA)

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CAPA Remediation

  • Root cause analysis

  • Implementation of corrective and preventive measures

  • Continuous improvement monitoring

  • Training and Support

  • Customized training programs

  • On-site and virtual training sessions

  • Ongoing support and guidance

CONTACT US

info@pinnacleconsultantservices.com

+1 (214) 400-3319

Dallas, TX

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