A commitment to understanding and implementing ISO requirements
Simplify and automate the process of understanding and implementing ISO requirements with RAIISON. We significantly benefit companies aiming to meet these standards efficiently. Additionally, the use of RAIISON to tailor recommendations to specific products or services adds a layer of personalization and relevance.
Get to market faster
We specialize in AI-assisted navigation of EU and US regulatory barriers for medical smart fabrics. The company’s primary goal is to help businesses navigate the complex landscape of regulations in both the European Union and the United States, ensuring compliance and smooth market entry for their innovative medical smart fabric products.
Regulatory Compliance
Our experts are well-versed in the latest EU and US regulations, such as the AI Act and the Medical Devices Regulation (EU) 2017/745. They help clients understand and comply with these regulations, ensuring that their medical smart fabrics products are safe, effective, and legally compliant.
Market Analysis
We conduct thorough market analysis to identify potential opportunities and challenges for clients looking to enter the EU and US markets. This includes assessing the competitive landscape, understanding customer needs, and identifying key trends in the medical smart fabrics industry.
Strategic Planning
Based on a market analysis, we work with clients to develop strategic plans that outline the best approach for market entry, including pricing strategies, distribution channels, and marketing tactics.
Navigating Regulatory Barriers
Our team of experts is well-equipped to help clients navigate the complex regulatory landscapes of both the EU and US, providing guidance and support throughout the process. This includes assisting with the submission of necessary approvals, managing compliance with post-market requirements, and addressing any potential regulatory challenges.
Post-market Support
We offer ongoing support to clients once their products are on the market, helping them maintain compliance with regulations, monitor market trends, and adapt their strategies as needed.
An array of resources
Our suite of products and professional services caters to the compliance needs of a diverse clientele, ranging from manufacturers to hospitals.
Raiisonable
- Use your own documents
- Identify compliance “holes”
- Auto-navigate the compliance road
Raiisonable Newsletter
- See the compliance world evolve.
- Case studies that celebrate compliance success.
- Exclusive access to emerging regulation.
“Raiison has saved us hundreds of hours of work and has unlocked insights we never thought possible.”
Tad Davis
CTO, The Millennium Project
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