Kim Walker Consulting

Our Services

At Kim Walker Consulting, we provide our clients support with global regulatory, clinical, and quality system requirements.

We offer guidance and hands-on assistance to optimize the time to market for your products. We provide Total Product Lifecycle regulatory support, regulatory strategy, design control support, clinical trial strategy and design, GCP compliance and audit capabilities, pre-market submissions, quality system audits, and post-marketing support. 

Listed below are some examples of the types of services we provide:

  • Regulatory Pre-Market Submission Strategies
  • US Pre-market Submissions – PMA, HDE, IDE, EUA, Pre-Sub/Q-Sub, and 510(k)
  • Global Pre-Market Submissions – European CE Mark Technical Files/Design Dossiers (MDR and IVDR), Canada Medical Device Licence, Japan, Australia, Latin America, etc.
  • CLIA Waiver Applications and Submissions
  • Clinical Trial Strategy, Design, and Project Management
  • GCP Auditing
  • Quality System Design, Development, and Auditing – including ISO 13485, FDA QSR, MDR/IVDR, MDSAP, Health Canada, Australia TGA, and Japan MHLW requirements
  • Adverse Event, MDR, and Vigilance Reporting Assistance
  • Recall and Field Corrective Action Assistance
  • Risk Management Design, Development, and Auditing – including ISO 14971 compliance
  • CAPA Design, Development, and Assistance
  • Import/Export Compliance Review and Assistance
  • Labeling Compliance Review and Assistance
  • Establishment Registration and Device Listing Assistance – including FDA and State of CA FDB
  • FDA Form 483 and Warning Letter Review and Assistance
  • Conduct assessments of client analytical studies, clinical studies, procedures, and programs to determine regulatory gaps and compliance
  • On-site training available on all the above listed topics
  • FDA, Notified Body, and Competent Authority liaison and negotiator
  • Due Diligence Auditing

If you require other regulatory services, please contact us to discuss your needs.

If we are not able to assist you, we are always glad to help you find the subject matter experts you need.

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