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Our Services:What We Do

BUSINESS CONSULTING

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 Here's what we can do for you:

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  • Project Management

  • EU MDR/IVDR gap assessment

  • Complaints Handling and Regulatory Reporting

  • QMS Remediation

  • Risk Management Integration

  • CAPA Management

  • Technical Documentation Remediation per EU MDR

  • PostMarket Surveillance

  • Audit Support

  • ​Quality Data Review/Trending

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We want all of our clients to experience the impressive level of professionalism when working with Compliance 360 Consulting. You can trust us to provide you with the best service resulting in regulatory compliance and quality improvement.

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WHAT: We provide Quality and Regulatory compliance service to Medical Device Manufacturers and Suppliers to ensure quality and compliance

 

WHY: Global regulations defines “WHAT”to comply with and it is critical to identify “HOW”to apply these regulatory requirements to specific needs. This is where our expertise and professional service will play a critical role to ensure compliance and effective and efficient operation using proven methods and techniques

 

HOW: We work with you to understand your goal and objectives. We create an Action Plan to meet your needs and assure compliance while tailoring the timeline and cost.

  • Perform gap assessment 

  • Develop Actions plan based on assessment results

  • Define structure and implementation strategy

  • Review and approve project plan

  • Define change management strategy and timeline

  • Implement and deploy change

  • Train the team

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Our Team: Tatyana Chorny

Owner/Director QRA

Principal Consultant

Since founding Compliance 360 Consulting LLC, Tatyana has played a crucial role in the continued success of the business. Her exceptional skill set, true passion and creativity has inspired company's growth.

Led global teams through challenging remediation and new process implementation

Supported over 30 internal and external global companies Audits in Medical Device industry

International Business experience in EU/APAC/LATAM/EMEA

Managed direct/indirect teams of various sizes (3-50+)

Managed Complaint Review boards and Field Actions Subcommittee

 Provided strategic directions for global Complaints, PostMarket Surveillance, Service and CAPA teams

Implemented software solution for multiple QMS elements across the global organizations

Implemented and deployed global Training programs

Six Sigma Certified

Holds MS Computer Engineering (MSCE)/Master of Business Administration (MBA)

As a Faculty Member Presented at the multiple Quality and Medical Device Conferences (ASQ, FDANEWS, CBI Complaint Congress 2012-2016, Q1 Production, CEBOS/QAD and Marcus Evans)

Compliance 360 Consulting LLC

Tatyana.Chorny@Compliance360ltd.com

+1(440) 503-7202

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