Medical Device compliance for modern teams

Streamline your compliance efforts and accelerate your product development timelines with our compliance solutions and software tools.

Solutions for Every Phase of your Company Lifecycle

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

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Product Development & Software Consulting

Software services and developer kits to jumpstart your compliant engineering

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Regulatory & Quality Consulting

Full-service and phase-appropriate regulatory and quality affairs consulting

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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.

Transition to Compliance

Setting up a QMS

Seamlessly set up compliant company operations operations with a quality management system.

Controlled Development

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.

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Combination Products

Maintain both your combination product quality needs in a unified set of tools designed specifically for drug + device products.

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Software as a Medical Device (SaaMD)

Navigate the complexities of managing software-only devices with our unique solutions and toolsets.

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+ Anything your team can think of

Regardless of your device type, our tools provide a comprehensive quality compliance framework to develop in.

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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.

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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.

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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.

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