Solutions
Solutions tailored for any product lifecycle stage
Different growth stages have different compliance needs. Our solutions are purpose-built to support your efforts, wherever you are in your development process.
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.
Early on in your project, it’s critical to balance ideation and early engineering efforts with preliminary compliance activities.
Our Starter Precompliance program will help direct your medical device commercialization efforts by providing a regulatory roadmap for your product development.
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.
During prototyping, it’s essential to have all the requirements that your engineering teams need to meet specified up front, and to confirm these with your regulatory agency.
Our Basic Precompliance program guides your team in this effort, allowing your company to prevent costly mistakes by building the right product, the first time.
Seamlessly set up compliant company operations with a quality management system built for modern teams.
When you're ready for a design freeze, the proper roll-out of your quality management system can make or break your commercialization efforts.
Our QMS Setup Services help teams set up their quality management system quickly and efficiently. Our unique software features, philosophies, training content ensure that the whole team is on board with compliance from day one.
Maintain your compliant quality operations and day to day development efforts with software add ons and support services.
Setting up a QMS is only the first step, teams must also use it on a regular basis to control their development processes.
As you move forward with your design, our advanced QMS software features and support services will help keep your team on track as they move towards regulatory approval.
Early on in your project, it’s critical to balance ideation and early engineering efforts with preliminary compliance activities.
Our Starter level Precompliance services will help direct your medical device commercialization efforts by providing a regulatory roadmap for your product development.
A Nemedio expert will introduce the right products for you