medical devices
A Finger on the Pulse of Regulatory Evolution
C2P Simplifies Regulatory Compliance for Medical Devices
With C2P’s efficient workflows and alert tools, you are safe in the knowledge that Regulations & Standards are tracked, responsibilities are allocated and actioned, Requirements are kept up to date and Evidence is saved all in one place.
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.
In Numbers
Medical Devices
64%
Growth in regulations over the past 5 years
23,120
in force and proposed regulations across the sector
195
countries monitored
Medical devicesINDUSTRY FIGURES
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.
standards management
- 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
Evidence management
- 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
Meet International Safety-Critical Standards
Our coverage of medical devices ensures that the medical devices you bring to market are safe and compliant for a global market.
Quickly Align with Regulatory Requirements
- 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 and inspection of medical devices under MDR means staying ahead is more critical than ever.
Accelerate Market Access for Your Products
- Stay up to date with the latest changes in Regulations & Standards so you can get your products to market faster and keep them there.
Keep Track of EU Medical Device Directives and Regulations
- C2P gives you access to 81,000+ product Regulations & Standards including customized daily alerts tailored to your Products & Markets.
Track ISO Standards for Quality and Risk Management
- Our medical device topic covers Quality Management Systems
Top 10 Regulatory Content
Summary overview of the regulatory content that matters to your business.
We need to ensure that products meet current, stringent environmental compliance legislation as well as be prepared for regulatory changes.
Tyler Shanks
Environmental Program Manager at National Instruments.
C2P has resulted in substantial time savings and we are confident that we have no gaps in coverage
Jay Mathewson
Manager of Environment, Health & Safety at Kodak Alaris
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.
Customer Experience
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The ability to filter alerts, coupled with the regulatory summaries provided by C2P, has resulted in substantial time savings for Kodak Alaris
Kodak receives comprehensive updates on regulatory activities in all geographies across their complete product portfolio, simplifying their regulatory process thanks to C2P
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Enhanced communication and collaboration within C2P gives greater transparency for all users, and results in reduced product-to-market timelines for Miele