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Navigate the complexities of the evolving medical devices and diagnostics market to quickly deliver safe products to patients.

YourEncore offers the expertise and experience you need to innovate and stay competitive.

With new regulations, advances in combination products, and a greater number of M&As, product recalls, and patient safety concerns, the medical devices and diagnostics environment is in a state of flux. YourEncore brings a holistic approach to solving your biggest challenges, recognizing that there is a strong inter-relationship between regulatory affairs, clinical evaluations, quality and regulatory compliance, and supply chain operations.

Our experts stand ready to help you address quality, regulatory, and compliance issues, ensure safety and efficacy with better data, find creative solutions for getting new products to market, and unlock manufacturing and supply chain value. Whether you need an immediate consultation with a technical expert, the wisdom of an executive-level strategist, or a team on the ground tomorrow, YourEncore can help drive results that matter.

Expertise:

Our experts bring an average of 25+ years of industry experience, allowing them to not only understand the evolving market, but to overcome challenges efficiently. They have run medical devices and diagnostics departments for the world’s largest companies, addressed recalls, M&A’s and key policy changes, and helped turn great device concepts into reality.

  • Asset Evaluation & Due Diligence
  • Agency/Relations/Communications
  • Key Policy Compliance
  • Submission Strategy & Preparation
  • Labeling/Promotions
  • Organizational Transformation
  • Quality Assurance & System Design
  • Clinical Evidence Strategies
  • Clinical Study Execution
  • Supply Chain & Procurement Management
  • Program/Process Management
  • Crisis Management

Solutions:

We develop solutions that address the unique needs of each client, and then move quickly, efficiently, and effectively to deliver results. Contact us to explore how we can help.

  • Stage-gate/Due Diligence
  • EU Medical Device Regulations (MDR) Guidance
  • innFusion Focused Problem-Solving

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