- Why Us
Product Management plays a critical role in your medical device company’s ability to reach commercial success and innovate rapidly.
Most medical device companies start out by manually managing bills of materials (BOMs) in spreadsheets, while others leverage disconnected tools that aren’t linked to quality events.
These tools are seemingly manageable - until they are not.
The truth is, as medical device companies look towards scaling, there are challenges that arise with managing product data in disconnected silos of information. This creates the risk of communication gaps and common errors that increase cost and delays during product development. These common challenges shift the focus even further from innovative design to cumbersome paperwork and data management.
We’ve all seen how complex quality investigations can get. And trying to dig deep into why a nonconformance or CAPA is issued can quickly become a prolonged process that dramatically lengthens the time to market or reduces profitability. You get stuck juggling product information separately from your QMS. With information scattered between databases, traceability is lost, which ultimately puts products and patients at risk.
There are many ways to address these situations before they happen, but it all starts with the ability to organize and connect your product information to design and quality actions.
The problem is that medical device companies don’t have a centralized platform to conduct both development and quality processes.
Now, there is a solution.
We found in a recent study that 70% of product development professionals believe that companies must invest in R&D solutions and tools to drive innovation.
Greenlight Guru Products is your solution that helps drive innovation and makes keeping up with the development and evolution of your devices easy.
With Greenlight Guru Products, you can easily manage your product and component information, create your bills of materials (BOMs) for your products and product families, and build full lifecycle traceability -- all in one place.
One of the challenges companies face is managing all the various processes they have to tackle. On top of that, having to find and flip between different files or tools is a hassle and things can get lost along the way. This leads to confusion, lack of clarity, and reduced efficiency.
With Products, you can design while you build and document your device - continuously improving your materials and processes. While you are documenting your Design Control components, you can build out your multi-level BOMs. Items and components can be organized into different product families that best suit your company - by location, process, product type, you name it.
Create a seamless flow from product development processes to DHF, while managing critical components of your device master record (DMR). Unlock new efficiencies and enhance supplier collaboration by eliminating the back and forth between tools.
We understand that as your company grows and evolves, so do your medical devices. Designs change over time and we want you to have the tools necessary to document those changes. By using paper or excel for product documentation, approval processes get messy. Storing those files and having them ready for an auditor can quickly become a hassle… or a big mistake.
With Products, your teams can conduct reviews, route, and approve changes to your designs with e-signatures. Gone are the days of printing and signing on paper! Track revisions of your materials as you build out your components and leverage full traceability with engineering change management as designs change through new product development and commercialization.
As companies grow and scale, the amount of documents piles up quickly. Finding the right paperwork you need to properly address a quality event shouldn’t be a challenge.
By leveraging Greenlight Guru’s medical device QMS software, your product information and quality events are all in one solution so you don’t need to go searching. Traceability is woven across Greenlight Guru so you can streamline regulatory submission or audits with a single source of truth for design control, risk, and product development.
Whether you are opening a CAPA or conducting a Design Review, you need to have the ability to link your components to events that require them. Your company’s critical design, quality, and product data is now all in one place, linkable, and can be cross-referenced.
With Greenlight Guru Products, you can control and collaborate on continuous product development while connecting to your device history file (DHF) and quality actions in a centralized system.
We want you to focus on innovation, not paperwork.
Want to say goodbye to spreadsheets and remove the data silos holding your development teams back?
Nick Tippmann is an experienced marketing professional lauded by colleagues, peers, and medical device professionals alike for his strategic contributions to Greenlight Guru from the time of the company’s inception. Previous to Greenlight Guru, he co-founded and led a media and event production company that was later...