Regulatory Environmental Sustainability

Navigate the regulatory environment, plan strategies, and implement solutions with DiGangi Consulting, LLC

International Global Worldwide

Meet stakeholder needs for medical devices and corporate social responsibility

Regulatory, environmental, and sustainability consulting services for manufacturers, investors, and start-ups

Core Consulting Services

 
  Regulatory Affairs
Regulatory strategies, meeting timing and resource needs. Manage device submissions to FDA.
  Premarket Notification
Plan and prepare FDA 510(k)s, anticipating and overcoming obstacles to market clearance.
 
 
  Corporate Social Responsibility (CSR)
Environmental considerations throughout the supply chain. Sustainability planning, implementation, and marketing.
  Environmental Engineering
Pollution Prevention (P2), Design for Environment (DfE), Life Cycle Analysis (LCA), and environmental management.
 
 

Rapidly bring your medical device to market

DiGangi Consulting leads you through standard and complex medical device regulatory matters

Regulatory Consulting Services (Medical Devices)

 

  • Premarket Notification, 510(k)
  • Determine and work with FDA's "Current Thinking" for your product type
  • Agency interactions (meetings, correspondence, resolution)
  • Technical file and device label development
  • Total Product Lifecycle (TPLC) management
  • Risk management
  • Establishment Registration (foreign and domestic)
  • Device Listing
  • Support for regulatory agency audits
 

Regulatory Consulting

Selecting a regulatory consultant

Article providing guidance on choosing the right regulatory consultant for your business. Read...

 

Simultaneously improve the environment and reduce operating costs

DiGangi Consulting champions sustainability projects

Environmental Consulting Services

Environment Green Global Sustainable

Meet needs of your business, customers, and securities exchanges

  • Corporate Social Responsibility (CSR)
  • Convert environmental improvement data into marketing materials
  • Cost-saving product design and process improvements
  • Minimize energy, water, and raw material usage
  • Reduce regulatory and waste disposal burdens
  • Design for Environment (DfE) metrics for entire product life-cycle
  • Utilize corporate social responsibility, life-cycle analysis, carbon footprint, and sustainability reporting terminology
Regulatory Environmental Sustainability Consulting

Developing strategies for success since 2003.

 

Austin, Texas

(805) 541-3344

Copyright 2017 DiGangi Consulting, LLC