A Finger on the Pulse of Regulatory Evolution
What We Do
Medical devices face their own unique regulatory landscape that has been increasingly complicated by several factors in recent years. The demand for more sustainable technology is being driven by both consumer demand and legislators, leading to regulatory implications. Global events such as Brexit and COVID-19 have also created unprecedented challenges. As devices become increasingly integrated with artificial intelligence and internet connection, new cybersecurity and data protection legislation is racing to keep up. And on top of all this, the new regulatory framework for IVDR and proposed amendments for registration & inspection of medical devices under MDR means staying ahead is more critical than ever.
Keep your finger on the pulse of change with C2P.
Growth in regulations over the past 5 years
in force and proposed regulations across the sector
All in one place
With C2P’s efficient workflows and alert tools, you are safe in the knowledge that Regulations and Standards are tracked, responsibilities are allocated and actioned, Requirements are kept up to date and Evidence is saved all in one place.
- Access to 70,000+ product regulations & standards
- Dashboards on progress, heat-maps covering impact of changed regulation
- Customized daily alerts tailored to your Products & Markets, covering proposed, new and changed regulations
- Workflow tools to help manage changed regulations from alert right through to recording impact and task management throughout the organization
- Automated alerts when your products’ compliance status changes due to updated Standards, or when new potentially applicable Standards arise
- Mark Standards where relevant, link to your product hierarchy and assign tasks to team members to action what’s required for your business
- Search by Text, Publisher, Geography, Status, Product Categories and Requirement type
- Immediate access to Product Standards relevant to your Product Hierarchy
- Create ‘live’ Specs for each product to highlight the relevant Requirements that need to be actioned
- Daily alerts on which Requirements need to be reviewed based on changing live linked Regulations and Standards
- Help focus your SME’s work by calling out the specific Requirements they need to review rather than a Regulation
- Improve team collaboration when sharing initial compliance requirements for new product design
- Create and maintain all Evidence documentation needed to prove compliance
- See if Evidence is up to date and the product is compliant for market access
- Get early insights into expiring Evidence to ensure the renewed Evidence is planned for, budgeted and procured from the lab in time
- Avoid periods of non compliance or risk to market access
Top 10 Topics
Summary overview of the regulatory topics that matter to your business.
Ask Our Experts
Direct access to our Global Regulatory Compliance Team, and Knowledge Partner Network.
Our global team of SME’s, with expertise across a diverse range of products, geographies, and policy areas, collaborate with our knowledge partners to monitor, research and report on all things compliance related.