Large Pharma's Device Partner for Combination Product Development

At EdgeOne Medical, we know large pharma companies need more than just expertise – they need a trusted partner who can adapt and flex to the needs of their organization.

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Services Built Around
Your Needs

Every large pharmaceutical company establishes their own philosophy toward device development, which includes determining how much and what to outsource. Their approach is shaped by their organizational design, internal strengths, capacity and device system experience.

As such, our services for large pharma don’t just come from a drop-down menu or taking a cookie cutter approach. They’ve evolved based on conversations with our clients.

EdgeOne Medical’s expertise and experience with a wide range of device configurations, together and with our ISO 13485 certified QMS and our FDA and EMA registered laboratories are designed to give you the flexibility your team needs to meet their combination products goals and objectives.

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Innovative Solutions to Pharma Challenges

At EdgeOne Medical, we’ve seen firsthand how large pharma companies struggle with specific pain points, from internal bottlenecks to balancing on-market product support and innovation. Here’s how we help solve these issues.

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Streamlining Internal Development

Some large pharma companies face delays in development due to the sheer size and complexity of their internal processes. We lead combination product development within our ISO 13485 certified QMS, streamlining the program and ensuring a compliant DHF transfer back into your QMS.

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Supporting On-Market Products

Balancing life cycle management with new product development can stretch teams too thin or result in compromises. Our clients engage us to handle routine device activities associated with on-market products, allowing your teams to focus on bringing the next innovation to life.

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Top Pharma Served

60+

Regulatory Submissions

50+

Design Verification Programs

FDA

Inspected Lab Facilities

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Your Trusted Partner for End-to-End Device Services

We understand that bringing a combination product to market is complex, and you've been through this before. Whether you’re starting a new device development program or handling post-market challenges, our expertise, QMS and in-house labs are here to support you every step of the way.

Testing Services

We offer a comprehensive suite of testing services, covering everything from initial concept evaluations to design verification studies to life-cycle management support for on-market products.

Our FDA and EMA registered labs support your testing programs with validated test methods and highest quality standards to ensure data integrity throughout the process.

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Consulting Services

Navigating regulatory agencies, managing quality systems and maintaining products on the market can get complicated and burdensome.

Whether it’s establishing a regulatory strategy, QMS optimization initiatives or life cycle management support, we’re here to step in and give your organization the lift needed to achieve its goals.

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End to End Development

Our comprehensive, end-to-end development services extend from initial concept to life-cycle management support.

With our device expertise and infrastructure, we are well positioned to accelerate your product to market.

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The EdgeOne Advantage

EdgeOne Medical’s infrastructure of an ISO 13485 certified QMS and FDA & EMA registered labs combined with our device expertise and client-centric approach provides advantages that extend directly to our clients.

Key components include:

  • Cross-functional, integrated team of device developers co-located with our laboratories increasing collaboration and execution of programs.
  • A full-scope ISO 13485 QMS that allows us to support across any/all stages of product life: development, testing, manufacturing and life cycle management.
  • Successfully FDA inspected laboratories providing confidence in operations and output of testing labs

Active management of a network of approved suppliers or subject matter experts including Human Factors, Statisticians, Conditioning, Packaging etc.

Ready to Bring Your Product to Market with Confidence?

Schedule a Consultation