Yellowstone Consultants llc
Medical Devices - Minneapolis, Minnesota, United States
Yellowstone Consultants llc Employees
Yellowstone Consultants llc Details
With over 20 years of proven success in navigating through international regulatory processes and quality compliance in the Medical Device Industry, our team provides consulting services to meet your needs.Services are offered on a project, interim and long term contract basis to meet our client needs. Statement of work, budget and periodic status reports are provided for all contracts.Regulatory Affairs and Clinical Support- Regulatory Strategy (US and International)- Prepare regulatory submissions and engage with regulatory agencies on your behalf (510k, de novo, Humanitarian Device Exemption, EU Class I, II and III devices)- Prepare for pre-approval inspections- Clinical Protocol and Report Writing- Clinical Evaluation Reports- Due Diligence auditsQuality Assurance / Quality Compliance- Certified Lead Auditing- Quality System Development and Improvement- FDA remediation - Design Controls- CAPA / Nonconforming Material / Supplier Quality- Post Market Surveillance and Complaint Handling- Quality System Integration- Change Management
