- Traditional Process
- Cool Process
| Why Cool AI? | Traditional Process | Cool Process |
| Why Cool AI? | ||
| Approval Process Time (months) | 60 | 6 |
| Cost of Compliance (€ k) | 150 | 30 |
| Documentation Effort (hours/month) | 100 | 10 |
| Error Rate in Compliance (%) | 10 | 0.0 |
MedTech Compliance is
just in time.
Cool AI is an intelligent AI-based SaaS platform designed to assist businesses in highly regulated industries with managing and navigating compliance and regulatory requirements.
How are we Unique
Let’s flip to check out
Typical Regulatory Aspects
for the innovative MedTech device manufecturers
MedTech Startup Journey
Journey Map
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Initial Market Research: Understand the regulatory landscape, particularly if targeting different geographical markets.
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Medical devices are classified into four classes based on risk. Classification determines the level of regulatory control and the conformity assessment route.
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Self-assessment: For low-risk devices (Class I), manufacturers can often self-certify.
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A Notified Body, which is an organization accredited by the competent authority in an EU member state to conduct conformity assessments.
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Demonstrates compliance with applicable EU regulations and allows for the device to be marketed in the European Economic Area (EEA).
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Businesses to adhere GDPR guidelines with no exception.
In the journey of a MedTech startup, the regulatory activities and engagements with legal consultants are critical and should be strategically planned across various stages. Key elements (but not limited to) are:
Why Cool AI?
Customer Testing (*On-going)
0
*
Expert Validation
0
Workshops
0
Strategic Partnership
0
+
Supported by
Case Studies
Traditional way
- Manual screening and research of existing and upcoming regulations
- Significant effort required to evaluate the impact
Cool way
- Automated provision of all relevant regulations, news, insights, and additional helpful information
- Tailored to your organization’s needs or personal user preferences
- Automatic crawling and aggregation of relevant information from thousands of sources
Traditional way
- Expensive data streams from a limited number of providers or decentralized manual data integration into proprietary workflows and tools
- Limited options: either substandard regulatory data quality or costly data packages
Cool way
- Easily customizable data streams via an intuitive API
- Automated processing, filtering, and structuring of public data, providing access to high-quality data at a fair price
Traditional way
- Time-consuming and repetitive process of building regulatory knowledge within business units
- Extensive reliance on external specialists due to a complex and unclear regulatory environment
- Labor-intensive coordination and harmonization with all stakeholders
Cool way
- Precise regulatory information organized by business topics, supplemented with additional helpful data and valuable insights
- Initial high-level impact assessments to facilitate and support a swift transition to in-depth functional analysis
- Intuitive team workspaces for collaborative deeper assessments and effective knowledge/result capturing (SPOT)
Traditional way
- Fragmented regulatory change management process
- Significant effort required to steer and control changes
- Lack of focus on the End-to-End process
Cool way
- Delivers a comprehensive End-to-End regulatory change management experience
- Enables controlled and secure execution of changes
- Provides continuous visibility of progress relative to deadlines
- A crucial step towards achieving an End-to-End audit-proof change management process
Let us handle
Compliance Complexity
& let you innovate.
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