Submit offer SaMD Regulatory Readiness: gap analysis against IEC 82304-1 and IEC 62304

1. General Information

Title of tender: SaMD Regulatory Readiness: gap analysis against IEC 82304-1 and IEC 62304
Company name: Scita Health ApS
Address: Absalonsgade 3, 4tv
CVR nr. 46117131
Date: 26 October 2026
Deadline for tender: 6 November 2026
Contact info: Lars Persson, CTO – lars@scita.health
Website: https://www.scita.health/Upload of tender info: Online, via the link in the published tender

2. Presentation of the Company

Scita Health ApS is a Danish healthtech startup developing standalone health software for women in perimenopause and menopause: an AI-powered health companion that combines clinical intelligence with behavioural science for personalised prevention of non-communicable diseases (NCDs).

The platform is built on an 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 and qualitative research with approximately 200 women. We will complete our current product test and the planning of a randomised controlled trial with Karolinska Institutet before setting a certification timeline.

3. Description of the Task

Before our clinical study, and before we build a quality management system, we need an independent view of how our software lifecycle processes and documentation meet IEC 82304-1:2016 and IEC 62304:2006+A1:2015.

Scope

•     A document-based, remote gap analysis of Scita Health’s software lifecycle processes and documentation against IEC 82304-1:2016 and IEC 62304:2006+A1:2015.

•     Scita Health completes the supplier’s requirements checklists, showing which documents address each requirement.

•     Up to 6 hours of advisory time to walk through the findings and explain the requirements, used no later than 26 November 2026.

Not included: advice on product design, development or implementation, or on the product’s intended purpose; MDR classification or conformity assessment; clinical evaluation; the EU AI Act.

4. Objectives, Deliverables and Timeline
The overarching objective is for Scita Health to know where its software lifecycle processes and documentation stand against IEC 82304-1 and IEC 62304, so that our team can close the gaps itself. This is knowledge-building and assessment, not implementation.

Deliverables

•     A written report that documents each gap against the relevant clause of both standards, with the reasoning for each finding.

•     The requirements checklists with the supplier’s annotations.

•     A walkthrough of the findings.

Timeline

•     Deadline for offers: 6 November 2026.

•     Report and walkthrough delivered no later than 26 November 2026.

•     Invoice to Danish Life Science Cluster issued no later than 26 November 2026.

5. Budget and Specification of an Offer
Fixed price, maximum DKK 65,000 excl. VAT, including all expenses. No additional time or costs without Scita Health’s prior written approval.

This engagement is funded through the Beyond Beta accelerator programme. Please provide a transparent breakdown so we can assess the correlation between price and quality.

Supplier requirements

•     Experience reviewing software documentation against IEC 62304 and IEC 82304-1 for medical device or health software.

•     The work must be organisationally separate from any notified body that may later assess the product.

We expect a written offer to include

•     Date of submission

•     Brief presentation of the bidder, including CVR number, contact details, and relevant references (particularly experience with IEC 62304 and IEC 82304-1)

•     Bidder’s proposed approach to solving the task, including estimated hours for the gap analysis and the advisory time

•     Price specification (hourly rate and total fixed price)

•     Proposed timeframe and end date (no later than 26 November 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 the gap analysis report, the annotated checklists and a walkthrough of the findings, which enable our team to do this work.