End-to-End Combination Product Development for Large Pharma

EdgeOne Medical offers end-to-end development services that can be tailored to fit your needs, whether you’re facing capacity issues, competing priorities or gaps in functional expertise.

With our ISO 13485 certified QMS, cross-functional teams and FDA & EMA registered labs, we have flexibility to take on the full or partial segments of the development program to accelerate your timeline to market.

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Your Alternative Device Team

Whether you’re looking to move faster than your internal systems/processes allow or need more bandwidth, consider EdgeOne Medical as your alternative device team. 

Key Pain Points We Solve

  • Capacity Issues: Extra bandwidth to keep projects moving when your teams are stretched thin.
  • Internal Processes: Streamlined development pathway when time to market is critical.
  • Flexibility: Operate within your QMS or ours.
  • Underperforming Partners: Step in to get programs unstuck and back on track to success.
  • Surprises!
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End-to-End Development Services for Combination Products

EdgeOne Medical offers a complete suite of integrated combination product development services that allow our device team to drive your device development program forward with your active participation. Our full-scope ISO 13485 certified QMS provides the backbone for our end-to-end services and offers you the flexibility to define the appropriate transition point for the DHF documentation back into your QMS. The following key service components collectively support end-to-end development of a combination product.

Device Development & Regulatory Strategies

Get strategic guidance on device development and regulatory pathways to set course for the program. We’ll work to align the development strategy based on the finalized regulatory strategy.

Design History File and Risk Management

Full DHF and Risk Management file creation expertly integrated with Human Factors activities, so you can meet current global regulatory requirements while reducing burden on your internal resources.

Verification Testing

Our comprehensive testing services ensures your product is tested per appropriate requirements and industry standards, giving you confidence in integrity of data and quality of test reports.

Regulatory Submissions

We guide your product through the submission process with expert preparation and submission of regulatory documents, ensuring smooth reviews/cycles with the FDA, EMA, and other global regulators.

Life Cycle Management

Support doesn’t end at launch. We provide ongoing services for design changes, global expansion, and post-market support, ensuring your product’s success long after it hits the market.

Complaint Investigations

We partner with you to create an integrated complaint investigation process that is responsive to real-world feedback.

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The EdgeOne Advantage

At EdgeOne Medical, we offer a unique advantage for large pharma: the flexibility to execute within our own ISO 13485 certified QMS, providing a faster and more streamlined path to market.

We act as an extension of your team, offering the agility and expertise to fill gaps in capacity or capability, without the red tape.

Our Competitive Edge

  • ISO 13485 certified QMS for accelerated development
  • Seamless integration with your internal teams and processes
  • DHF and product ownership remains with you
  • Proven track record in combination product development
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Ready to Bring Your Product to Market with Confidence?

Schedule a Consultation