Nemedio Starter Precompliance Package

Built for medical device companies in the earliest stages of R&D activities
Nemedio platform screen
Nemedio is a platform for agile, compliant medtech development, helping you build with efficiency and commercialize faster.

READY TO GET STARTED? Let'S CHAT.

Trust Us, Compliance Isn't for Later

By helping you design a product with a regulatory path in mind, we'll make sure that you build the right device, the first time.
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Engineer with Purpose

Design your product with a regulatory path in mind

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Prevent Costly Mistakes

Understand and build towards your specific engineering requirements

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Plan Confidently

Estimate regulatory costs & resources needed for fundraising

Nemedio Basic Precompliance Package

WHAT'S INCLUDED

Precompliance Dashboard

We’ll guide you through what activities should be completed at the earliest stages of your product development.

Design History File Gap Assessment

Based on the materials and information you submit, we’ll be able to provide feedback and recommendations regarding the following:

  • Design materials
  • Device description
  • Device safety characteristics
  • Suppliers and materials
  • Software architecture
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Special Product Guidance

If you’re building a non-standard product, we’ll be able to provide additional guidance.

  • Combination Products
  • Advanced Robotic Devices
  • Software as a Medical Device
  • Complex Electromechanical Devices
Only two steps required to answer your most burning question...

How long will it take and how much will it cost to get my device through FDA?

step 1

Get us up to speed about you and your product

Tell us about your company and device by answering some preliminary questions and submitting any existing documentation.

step 2

Receive a report of findings and recommendations

We’ll review your materials and send you a report of our recommendations on how to take them to the next level.

GET STARTED NOW

With You Every Step of the Way

Nemedio offers additional services to finally put your questions to rest and support your path towards FDA clearance and beyond.
  • Regulatory Analysis and Planning
  • Standards Analysis and Derivation
  • Instructions for Use Development
  • Design Control Training and Design Input Generation
  • Introductory Risk Management Activities
  • Human Factors Engineering Planning
  • FDA Pre-Submission Meeting Preparation and Follow-up
  • QMS Software Setup & Application
  • QMS Validation
  • SOP Implementation and Training
  • Supplier Qualification and Quality Agreement Negotiation
  • Design History File Records Creation
  • Validation and Verification Protocols
  • Device Software Validation
  • Test Lab Management and Oversight
  • Manufacturing Records Creation
  • Post-market Surveillance Activity Planning & Support
  • Maintenance of Training Plans and Records

Let's Work Together

We want to help bring your mission-critical device to market. Get in touch to learn more.