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Press Release

Pittsburgh Based Startup is Mapping the Global Regulatory Landscape for Medical Devices

Posted on: 06 Mar 18

RIMSYS is excited to unveil the first-ever software solution to help medical device companies effectively manage regulations across the globe. Mismanaged information pertaining to regulations can, unfortunately, delay or even block the entry of medical devices to the markets that need them the most. RIMSYS solves this problem by providing a platform companies can use to understand the regulations that affect product pipelines and portfolios.

“Getting a product to market is tough enough from a development standpoint,” says James Gianoutsos, founder of RIMSYS. “However, complying with each country’s requirements accurately and on-time can make or break its entry. That’s where RIMSYS shines.”

To develop RIMSYS, Gianoutsos drew from his extensive industry experience and garnered insight and feedback from a diverse advisory board composed of top regulatory leaders from global medical device companies. These leaders shared that they often hire specialized consultants to help manage changing regulations and product requirements, as their internal teams are often not fully equipped to handle compliance issues on their own. RIMSYS fills these gaps by providing an interactive platform for teams to manage products, countries, regulations, standards, guidelines, accounts, contacts and even regulatory bodies.

"Professionals need a way to properly manage this information,” Gianoutsos says. “Regulatory intelligence by itself isn’t of value until your organization applies it. How does this information impact products? How does it impact country representatives? Our system doesn’t allow critical action items to fall through the cracks.”

According to a survey of 100 MedTech companies, 50% of regulatory professionals currently aren’t aware of where their companies are selling their products, if their products’ registrations are current, or if their products were properly registered in the first place. RIMSYS provides these professionals with up-to-date information at their fingertips, in addition to providing clarity on how the regulatory environment is currently, or will be, affecting their products.

“We know this isn’t just a medical device industry issue. It’s a general regulatory management issue,” Gianoutsos says. “That said, there is opportunity to expand RIMSYS beyond medical devices. However, the company’s current focus is where the biggest need is, and that’s the medical device industry.”

About RIMSYS: RIMSYS Regulatory Software ( is a B2B cloud-based multi-tenant SaaS application that provides medical device manufacturing companies the ability to manage the global regulatory landscape and understand the relationships between products, countries, regulations, standards, guidelines, accounts, contacts, and regulatory bodies.

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Business Wire

Last updated on: 06/03/2018

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