We’re excited to announce that we’ve closed $16M in Series A financing led by Bessemer Venture Partners, with participation from Allos Ventures, Private Opportunities, and Innovation Works. Rimsys was created because there wasn’t a viable regulatory information management (RIM) solution on the market for medtech companies, leaving regulatory affairs (RA) teams to manage increasingly complex work with spreadsheets. The growth that we’ve seen (3X this year), and the work we’ve done with some of the world’s largest medtech companies including Johnson & Johnson, Terumo, Siemens, and the Cooper Companies, makes us incredibly excited about what’s to come.

Regulatory digitization and automation for the medtech industry

The regulatory landscape for medical device, in vitro diagnostic, and medical software products is growing increasingly complex. The implementation of the new European Union Medical Device Regulations in May, to be followed by the In Vitro Diagnostic Regulations next year, brought new general safety and performance, unique device identification, and post-market surveillance requirements that manufacturers must comply with. Research from MedTech Europe predicts that as many as 76% of products will be withdrawn from the market as a result.

Growing complexity isn’t limited to the EU region. This year, Australia has released new essential principles requirements, Canada has expanded post-market requirements, and China has launched a new UDI system. The simple fact is that the largely manual way that RA teams have managed processes won’t work moving forward.

The Rimsys RIM Platform provides an automated, digital alternative to these traditional approaches. It’s a 100% cloud-based software solution that’s specifically designed around medtech regulatory activities and processes.

Rimsys provides a centralized "single source of truth" for all regulatory information and documents. It automates regulatory submissions, including product and UDI registrations, and monitors expiration dates, applicable standards, and regulations for changes that might impact products. It’s a single, integrated solution that supports the full breadth of regulatory activities, and organizes all of it at the individual product level, giving medtech companies unprecedented visibility into and control over their regulatory processes.

New leadership to drive continued growth

We’re also excited to announce new company leadership that will help us through our next phase of growth. We’ve added two new executive leaders with extensive industry experience: Adam Price, former head of post-market surveillance at Philips, and Christine Robertson, former IT leader supporting regulatory at Thermo Fisher Scientific. Adam will lead post-market strategy for Rimsys, developing new offerings to streamline and simplify that part of the regulatory lifecycle. Christine will lead implementation and professional services, bringing best-practices from successful large-scale RIM deployments to all of our customers.

We’ve also added two new board members: Andrew Hedin, Partner at Bessemer Ventures, and Eric Boduch, Co-founder of Pendo, a $2.6B SaaS company that helps companies develop better software products. Both bring a wealth of start-up, SaaS, and industry experience that will be incredibly valuable as we scale the company.

What’s next

Our goal is to build a comprehensive software platform for medtech regulatory affairs that supports activities across the regulatory lifecycle from pre-market to market placement to post-market surveillance. This year we became the first vendor to offer UDI management directly integrated with product registration data. And we announced a new partnership with Clarivate to bring world-class regulatory intelligence into the Rimsys platform where customers can leverage it directly within automated processes.

We will continue to expand our capabilities at an even faster pace, with new collaborative submission authoring, electronic transmission, regulatory intelligence, document management, and post-market surveillance features coming to the platform. We will also continue to expand our team with a new UK office to better serve the European market, and a number of new roles across the company. If you’re interested in helping medtech companies get lifesaving products to market more quickly, we’d love for you to join our team.

Learn more about Rimsys

We’d love to show you how the Rimsys RIM Platform can help medtech companies streamline processes across the regulatory lifecycle, strengthen global compliance, and get new products to market faster. Contact us to schedule a free custom demo.