Your starting point for classification, predicates, pathways, guidances, standards and regulatory controls. Sherpa gives you grounded direction from the first description of your device.
FDA Reviewer
A dedicated reviewer that checks your submission materials, finds gaps and highlights required improvements. Clear recommendations supported by evidence.
FDA Researcher
A research engine built on 155k regulatory documents. It finds the standards, codes, guidances and examples that matter for your device without manual searching.
To provide the Guideways Service, Guideways B.V. (“Guideways”, “we”, “us”) engages third-party service providers to assist with data processing activities. These providers act as “Sub-processors” as defined in our Terms and Conditions and the Data Processing Agreement (DPA) included therein.
We conduct due diligence on the security and privacy practices of our Sub-processors to ensure they provide a level of security and privacy appropriate to the data they process.
1. Infrastructure & Application Hosting
These providers support the core functionality, hosting, and delivery of the Guideways SaaS platform.
Sub-processor
Entity Location
Processing Location
Purpose & Activities
Amazon Web Services (AWS)
Luxembourg / USA
European Union (primary)
Cloud Infrastructure: Hosting the application, database storage, and secure content delivery. User Identity: Managing user authentication and login sessions. Communications: Sending transactional emails (e.g., password resets, notifications).
2. Artificial Intelligence & Machine Learning
We utilize state-of-the-art AI models to process documents and generate regulatory insights. Note: We utilize “Enterprise” agreements with these providers to ensure your data is not used to train their foundational public models.
Sub-processor
Entity Location
Processing Location
Purpose & Activities
Google Cloud (Vertex AI)
Ireland / USA
European Union
AI Inference: Processing text inputs to generate regulatory summaries and content. Fine-tuning: Training specific Guideways models on isolated, secure instances.
Microsoft (Azure AI Foundry)
Ireland / USA
European Union
AI Inference: Processing complex regulatory queries and document analysis. Fine-tuning: Training specific Guideways models on isolated, secure instances.
3. Billing & Business Operations
These providers assist with business administration and payment processing.
Sub-processor
Entity Location
Processing Location
Purpose & Activities
Stripe
Ireland / USA
Global / USA
Payment Processing: Securely processing subscription payments and managing billing history. Data Processed: Billing contact information (Name, Email, Address) and payment method metadata.
Updates & Notifications
As our business grows and evolves, the Sub-processors we engage may also change. We will provide the Client with notice of any new Sub-processors to the extent required under the our Terms and Conditions, along with posting such updates here.