Compliance & Risks

Within the medical devices space, there has been a 64 percent growth in regulations over the past five years, with over 12,694 in force and 870 proposed regulations.

With the ever-increasing demand for more transparency and sustainability from both regulators and consumers alike, healthcare organizations (especially, businesses that are involved in the design, manufacture, and sale of medical devices) struggle to navigate a unique and complex regulatory landscape. This is where Compliance & Risks steps in.

“We combine our enterprise grade technology platform, global regulatory content, and subject matter expertise to help ensure organizations achieve, maintain, and expand market access for their products globally,” says Matt Kuo, the Chief Product Officer of Compliance & Risks. “We are trusted by the world’s biggest brands including Carestream, Abbott Laboratories, Thermo Fisher Scientific, GE Healthcare, and Novo Nordisk.”

Compliance & Risks’ powerful enterprise platform, C2P, provides comprehensive capabilities that enable organizations to demonstrate their compliance, for what is required, driven by global regulations and standards. C2P provides organizations a single place to manage the entire product compliance lifecycle, with continual monitoring of regulatory changes, that accelerates their time-to-market and ensures business continuity.

Given the rapid growth and changing pace of regulation within the healthcare space, C2P is viewed as an invaluable tool and resource by Compliance & Risks’ customers. With regulatory coverage in 195 countries, regulatory heatmaps showing what’s hot and where, intelligent search and productivity tools to improve team collaboration, compliance teams are in the driving seat and can manage their regulatory obligations easier than ever before.

The platform, combined with Compliance & Risks’ depth and breadth of expertise, enables customers to overcome a multitude of barriers to achieve, maintain and expand market access globally. With C2P, organizations have access to over 70,000+ product regulations and standards. C2P also helps organizations to filter an ocean of regulations and standards down to what is relevant to their products. They can analyze their progress and impacts of regulations via dashboards and receive bespoke and tailored daily alerts to any new and proposed regulatory changes.

C2P’s advanced workflows, content, and alerts help organizations and their divisions achieve greater efficiencies by breaking down silos. Customers have seen transformative results, including improved collaboration with stakeholders, greater transparency across departments, improved team efficiency, accelerated time-to-market for products, and better visibility into potential areas of risk.

“Ultimately, C2P is the catalyst for organizations to transform their compliance requirements and departmental activities into a strategic, competitive advantage,” says Kuo.

Compliance & Risks brings over 20 years of experience. The company continues to help the world’s leading brands manage their market access and compliance requirements through unrivaled customer experience provided by C2P’s technology and workflows as well as its team of regulatory experts.