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.

Engineer with Purpose

Design your product with a regulatory path in mind

Prevent Costly Mistakes

Understand and build towards your specific engineering requirements

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

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?

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.

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.

GET IN TOUCH

Nemedio Starter Precompliance Package