Submit offer Training Program Sipho: V&V of Medical Devices in Accordance with IEC 62366-1 and Relevant ISO Standards

 1. GENERAL INFORMATION:  

Title of tender:  Training Program: V&V of Medical Devices in Accordance with IEC 62366-1 and Relevant ISO Standards

Your company’s name: Sipho - Sustainable Medicare ApS

Address: Krudttårnsvej 69, 2791 Dragør

CVR nr.:   42445517

Date:  23 juni 2026

Deadline for tender:   17 juli 2026

For further questions, contact info:   trine@siphomedicare.com +4529890413  

Upload of tender info:  ida@siphomedicare.com +4521740107  

Phone and e-mail:  trine@siphomedicare.com +4529890413 

2. PRESENTATION OF COMPANY:  

Sipho – Sustainable Medicare is a company dedicated to bringing more sustainable products into hospitals in Europe. We're challenging the single‑use culture in healthcare. By replacing the disposable plunger of an enteral syringe with a reusable component, we introduce circular-economy principles into clinical care and cut plastic use by 35%.

We introduce a hybrid syringe where the plunger will be able to reuse, and the barrel and gasket will be kept single-use.

Sipho is driven by two co-founders who have developed the more sustainable syringe in close collaboration with Region Hovedstaden and clinicians at the Department of Nutrition (Ernæringsenheden).

3. DESCRIPTION OF THE TASK UNDER MARKET EVALUATION:  

The training program cover the following four core modules:

●         Module 1: Human Factors Engineering & User Needs (IEC 62366-1)

○         Competence development in structuring and planning user testing in accordance with the usability standard IEC 62366-1.

○         Training in methodologies for identifying user needs and translating these into concrete, verifiable product requirements (Design Inputs).

●         Module 2: Protocol Writing & Quantitative Comparative Testing

○         Training in drafting professional test protocols for user testing.

○         Knowledge on how quantitative testing methodologies compare our solution with existing products/processes on the market – with a specific focus on parameters such as cleanability, hygiene, and mechanical wear.

●         Module 3: Laboratory Testing for Cleaning and Hygiene

○         Strategic understanding of how laboratory tests (lab tests) are planned, executed, and documented when evaluating and validating a product's hygienic state after repeated cleaning and disinfection.

●         Module 4: Accelerated Aging and Functional Wear (ISO Standards)

○         Analysing relevant ISO standards for lifetime testing (e.g., accelerated aging and mechanical wear).

○         Training in planning and setting up test protocols that simulate the product's real-world lifecycle in the hands of the end-user.

4. TASK OBJECTIVES AND SUCCESS CRITERIA: 

The objective of this task is to upskill our team to independently handle and structure the Verification and Validation (V&V) phase, allowing us to integrate usability, hygiene requirements, and lifetime testing early and effectively into our product development lifecycle.

Success criteria and measurable deliverables:

●         Workshop Material: A complete set of presentations, guides, and checklists for the reviewed standards (IEC 62366-1, ISO standards) to serve as a future reference manual.

●         Protocol Templates: Professional and operational templates in Google Docs format for future protocol writing within user testing, hygiene testing, and lifetime testing.

●         Targeted Feedback Session: A dedicated session where the bidder evaluates and provides expert feedback on a specific draft of a test plan or protocol developed by our team during the course of the project.

5. BUDGET AND SPECIFICATION OF AN OFFER:  

43.000 dkk ex. VAT

The submission of the bidder is expected to be on 17 July. 

The program starts 3 August, ensures the team have completed the first module and is ready for the first agreed Rigshospitalet ward test on 12 August, and runs in parallel until its end date of 30 September 2026.  

6. BACKGROUND FOR THE TENDER: 

Sipho is currently at a stage where its market readiness must be substantiated through structured, standards-based documentation. While we are confident in the product's performance, we have observed that legal manufacturers and distributors express uncertainty regarding its adoption in hospital settings, and that hygiene nurses raise questions about the cleaning protocol in particular.

The purpose of this task is therefore to upskill our team so that we can independently plan, structure, and document the testing and validation required to bring Sipho through this stage, in accordance with the relevant standards (IEC 62366-1 and applicable ISO standards). The training program is delivered across four modules covering human factors engineering and user needs, protocol writing and strategic understanding regarding quantitative comparative testing, laboratory testing for cleaning and hygiene testing. 

Sipho recognises the need to conduct formal user testing and product validation in order to address them with objective evidence and thereby strengthen our arguments toward both partners and end-users.