Submit offer MDR/SaMD Regulatory Readiness Assessment & Architecture Review

1. General Information 

Title of tender: MDR/SaMD Regulatory Readiness Assessment & Architecture Review for AI-powered Clinical Decision Support Software
Company name: Scita Health ApS
Address: Absalonsgade 3, 4tv
CVR nr. 46117131
Date: 10 March 2026
Deadline for tender: 31 March 2026
Contact info: Lars Persson, CTO – Lars@scita.health
Website: https://www.scita.health/

2. Presentation of the Company
Scita Health ApS is a Danish healthtech startup developing an AI-powered health companion and Clinical Decision Support System (CDSS) for perimenopausal women, combining clinical intelligence with behavioural science for personalised non-communicable disease (NCD) prevention. 

The platform is built on a EU-compliant stack (Xano backend, Next.js frontend, n8n automation, WhatsApp via Twilio, Claude API for personalised communication) with a deterministic safety architecture that separates clinical decision-making from AI communication layers. 

We have completed proof-of-concept testing, qualitative research with approximately 200 women, and have a 55-person waitlist. We are launching a 50-woman pilot in 2026 and have a confirmed research collaboration with Karolinska Institutet (PI: Assoc. Prof. Shireen Sindi) for an N=200 RCT intended to generate clinical evidence supporting MDR Class IIa certification. Our Eurostars application deadline is 19 March 2026. 

3. Description of the Task
Scita Health requires specialist advisory input from an expert with direct experience taking Software as a Medical Device (SaMD) through MDR certification, ideally including IEC 62304 software lifecycle documentation for non-traditional (low-code) architectures. 

The task comprises four interconnected advisory workstreams: 

3.1 Architecture Review Mapped to IEC 62304

Our platform architecture separates clinical logic from AI-generated communication. The backend (Xano) provides the API layer and PostgreSQL database, hosting a deterministic scoring engine via auditable server-side function stacks. Workflow orchestration (n8n) manages automation and enforces safety logic. The frontend (Next.js) provides the user interface, while WhatsApp (via Twilio) serves as the primary conversational channel for daily health guidance and check-ins. The Anthropic Claude API is integrated for natural language generation, restricted to communication personalisation and evidence summarisation; clinical and safety-critical decisions are computed deterministically and remain isolated from the language model's logic path. The system is developed by the founding team using AI-assisted engineering tools (e.g., Anthropic Claude Code) within a controlled software development lifecycle, where all outputs are verified and validated against defined software requirements. Evidence-based guidance is supported by a Retrieval-Augmented Generation (RAG) system drawing from a curated PubMed corpus, with full citation traceability. 

We need the consultant to review our current architecture and provide a practical assessment of how this maps to IEC 62304 software lifecycle expectations. Specifically, we need guidance on how to document software units, integration, and system testing when the underlying platform components are managed services rather than custom-written code. The goal is that Scita’s team acquires the knowledge and frameworks to produce IEC 62304-compliant documentation themselves going forward. 

3.2 Intended Purpose Statement 

We have a draft Intended Purpose that positions the platform as clinical decision support (not diagnostic). We need the consultant to review and refine this statement, ensuring it correctly balances the clarity of claims against the evidence burden required for MDR Class IIa. This includes advising on how the planned RCT evidence maps to the claims we intend to make, and where we should be more or less specific. 

3.3 Classification Confirmation 

We are proceeding on the assumption of MDR Class IIa (Rule 11) for software that provides information used to make clinical decisions regarding chronic disease risk management. We need the consultant to validate or challenge this classification based on the actual functionality of our platform, including the five-domain risk scoring system and the provider-facing clinical summary. 

3.4 Prioritised Gap Analysis & Compliance Roadmap 

Based on the above three workstreams, we need a prioritised gap analysis that identifies what must be in place before we begin the RCT (to ensure trial data is regulatory-usable), what must be in place for Notified Body submission, and what can be addressed later. This should result in a concrete, actionable compliance plan with timeline guidance. 

4. Task Objectives and Success Criteria
The overarching objective is for Scita Health to acquire the regulatory competencies needed to manage MDR compliance for SaMD internally, with expert guidance. This is knowledge-building and assessment, not implementation. 

Success criteria: 

1. Scita’s technical team can independently produce IEC 62304-style documentation for their no-code/low-code architecture, using the frameworks and templates provided by the consultant.

2. An Intended Purpose Statement is delivered that has been reviewed and refined by the consultant, with a documented rationale for claim scope decisions. 

3. Classification is confirmed or revised with a written rationale referencing applicable MDR rules. 

4. A prioritised gap analysis is delivered as a written document, distinguishing pre-RCT requirements from post-RCT requirements, with estimated effort and timeline. 

5. Scita’s team demonstrates increased competency through the ability to describe their regulatory pathway and documentation requirements to external parties (e.g. Eurostars application, investor discussions). 

5. Budget and Specification of an Offer 

43.000 DKK ex. VAT

This engagement is funded through the Beyond Beta accelerator programme. We invite bidders to propose a scope and price that reflects the complexity of the task. Please provide a transparent breakdown so we can assess the correlation between price and quality 

We expect a written offer to include: 

• Date of submission 

• Brief presentation of the bidder, including CVR number, contact details, and relevant references (particularly SaMD/MDR certification experience) 

• Bidder’s proposed approach to solving the task, including estimated hours per workstream 

• Price specification (hourly rate and total estimate) 

• Proposed timeframe and end date (noting our Eurostars deadline of 19 March 2026 and RCT start in Q2/Q3 2026) 

• Any conditions for the offer 

6. Background for the Tender
Beyond Beta is subject to a number of requirements for good, healthy financial management, including documentation that the agreed price for external purchases is an expression of the market price. This tender is part of these requirements. 

We emphasize that the bidder must only make an offer on the requested task. Services of executing or implementing nature cannot be approved. The winning bid is chosen based on an assessment of the best correlation between price and quality. 

For clarity: we are seeking advisory and assessment services that transfer competency to our team. We are not seeking a consultant to build our QMS, write our technical file, or implement our compliance processes. The deliverables are assessments, reviews, frameworks, and guidance that enable our team to do this work.