Consulting Services
for Large Pharma

EdgeOne Medical offers consulting services from our core functional departments, including quality, regulatory, engineering, and project management. Whether you need support with QMS related activities, assistance with a regulatory strategy or remediating existing technical files, our team offers support solutions based on your unique needs and goals.

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Your Extended Device Team

The balancing act of maintaining current systems, processes and products on market while leading new product development initiatives can stretch an organization.

This balancing act often creates internal competing priorities that directly impact progress and sometimes result in compromises.

Don’t compromise! Our team of device experts across all functional roles are ready to seamlessly integrate into your team on a project-by-project basis.

Whether you give us the highest or lowest priority on your list, we’re here to help make forward progress and achieve your objectives.

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Expert Consulting Services for All Device Stages

As a company led by experts from key functional areas necessary to develop and launch a medical device/combination product, EdgeOne Medical offers the resources needed to support your organizational and product initiatives.

The following are the most requested consulting services by our large pharma clients.

Quality Services

Rely on our team to help you maintain compliance of your internal QMS processes and procedures:

  • Supplier Qualification Audits
  • QMS procedure updates
  • Training on Specialty Topics: Risk Management, Test Method Validations, etc.
  • QMS Annual Reviews

Remediation Services

Let our product development experts help update your on-market files to comply with current regulations:

  • Risk Management File Remediation
  • DHF Remediation
  • MDR Technical File Remediation

Regulatory Services

Expert regulatory consulting to guide you through every step of process, including:

  • Regulatory Strategy
  • Submission Authoring: 510(k) and Module 3 and 5 of IND, BLA, NDA
  • Briefing Book Authoring
  • CE Technical File Authoring & Submission
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The EdgeOne Advantage

EdgeOne Medical’s functional departments are led by seasoned experts in medical device and combination product development. They are active practitioners who live and breathe the challenges and innovations in the combination product every day, in service of our clients.

Our experts also go beyond solving real-world challenges for our clients. They actively engage with the industry, sharing their expertise at leading conferences through technical talks and panel discussions.

Knowledge is meant to be shared, and we look forward to bringing our insights and best practices to every consulting engagement with our clients.

Unique Benefits

  • Deep domain expertise in quality, regulatory, risk management and device  development
  • In-house testing labs co-located with product development experts
  • Network of qualified suppliers and subcontractors through EdgeOne Medical QMS

Ready to Bring Your Product to Market with Confidence?