Medical Device compliance for modern teams
Streamline your compliance efforts and accelerate your product development timelines with our compliance solutions and software tools.
Products & Services
Tools and Experience to support your development of best-in-class medical devices
Nemedio is here to support your team from the very start of your product development cycle, through regulatory checks, to achieving compliance and maintaining post-market compliance .
We have the right solution wherever you are in the process.
Compliance & Quality Management Software Tools
Scalable compliance tools, for all phases of your product lifecycle
Product Development & Software Consulting
Software services and developer kits to jumpstart your compliant engineering
Regulatory & Quality Consulting
Full-service and phase-appropriate regulatory and quality affairs consulting
Stage appropriate solutions
Solutions tailored for every stage of the medical device development lifecycle
Dig into our lifecycle appropriate solutions to learn how Nemdedio will guide your team and product development through each stage of the compliance roadmap.
Starter Precompliance
Mitigate your go-to-market risk by understanding your device’s regulatory and development pathway, so you can plan ahead for a successful product launch.
Basic Precompliance
Engineer confidently by taking into account your device’s specific regulatory and testing constraints. Plan ahead by confirming your plans with FDA & other regulatory agencies.
Setting up a QMS
Seamlessly set up compliant company operations operations with a quality management system.
Quality Engineering & Development Support
Maintain your compliant quality operations and day to day development efforts with software add ons and support services.
Postmarket Compliance Support & Tooling
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Advanced development capabilities
Supporting a wide range of core medical device technologies
From wearables, to implantables, to software as a medical device, our offerings are as diverse as the medical devices that our customers build. Our solutions leverage best practices for your device’s archetype, saving your time and development costs.
Software Driven Devices
Overcome the additional challenges that come with the development of complex electromechanical products with our modern tooling.
Combination Products
Maintain both your combination product quality needs in a unified set of tools designed specifically for drug + device products.
Software as a Medical Device (SaaMD)
Navigate the complexities of managing software-only devices with our unique solutions and toolsets.
+ Anything your team can think of
Regardless of your device type, our tools provide a comprehensive quality compliance framework to develop in.
The Nemedio difference
A true partner in all aspects of compliant medical device development
Compliance in the medical device space is a journey that starts from when you first start sketching your new idea, through commercialization, and to the retirement of a product line.
Nemedio’s solutions and tools provide support for all phases on this journey.
Right-Sizing your efforts with Pre-Compliance
Nemedio is the only solution to ease your team into compliance. Prototype confidently using our methods, knowing that the compliance has been taken care of for the phase that you’re in.
Providing dedicated program leads committed to your success
Your account manager is more than a glorified salesperson. They’re your compliance “compass” providing strategy and insight into your commercialization or remediation effort.
Fully integrating product development and quality
Tear down the walls that separate quality and engineering with our solutions and methods that put quality at the forefront and empower everyone on your team to be responsible for quality.