Nemedio preQS Compliance Tools

Geared to help early stage modern engineering teams move fast and mitigate risk
Nemedio platform screen
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Why Nemedio?

Nemedio is a platform for agile, compliant medtech development, helping you build with efficiency and commercialize faster.

Engineer with Purpose

Design your product with a regulatory path in mind.

  • Store regulatory planning documents and standards
  • Take credit for the risks and mitigations your engineers intuitively work through
  • Structure and filter deliverables by engineering groups using our tags function

Prevent Costly Mistakes

Understand and build towards your specific engineering requirements.

  • Establish and build your requirements directly from applicable standards and sources
  • Annotate and store risks and mitigations in parallel with device engineering
  • Trace data types intuitively and flexibly

Establish a Single Source of Truth

Access all your engineering, regulatory, and design materials in one place.

  • Seamless data management from user needs to design transfer to generate DHFs
  • Manage approvals with clear customizable workflows

With You Every Step of the Way

Nemedio offers additional services to support your path towards FDA clearance.
  • Regulatory Analysis and Planning
  • Introductory Risk Management Activities
  • Review and Development Support for Device Description and Instructions for Use
  • Generation of Design Inputs
  • Test Planning
  • Regulatory Affairs Support for FDA Pre-Submission Meeting Preparation and Follow-up

Trust Us, Compliance Isn’t for Later

Quality and regulatory work don’t need to be at odds with agile product development. 
You just have to know what’s most important at each stage.
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Let's Work Together

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