Submit offer Kompetenceudvikling – CE-mærkning (MDR) Pebbla

1. GENERAL INFORMATION:  

Title of tender: Kompetenceudvikling – CE-mærkning (MDR) Pebbla

Holbergsgade 30, 8000 Aarhus C  

CVR nr.: 46136292

Dato: 06.07.2026

Tilbudsfrist: 14.08.2026 

For further questions, contact info: 

Line Baunsgaard

Phone and e-mail: +2621 8104, line@pebbla.dk, or

Stephanie Schouten

Phone and e-mail: +3660 4066, stephanie@pebbla.dk

LinkedIn: http://linkedin.com/company/pebbla/?viewAsMember=true 

2. PRESENTATION OF COMPANY:  

Pebbla is a Danish health technology company founded in 2025, developing innovative pelvic floor training devices for women with pelvic floor dysfunction and operating within the women's health (femtech) sector. 

We are developing an external pelvic floor trainer designed to support women experiencing symptoms associated with pelvic floor dysfunction, including urinary incontinence, pelvic organ prolapse, pelvic pain, as well as reduced awareness of and connection to their pelvic floor muscles.

Grounded in evidence-based principles for pelvic floor training, the device provides intuitive and credible pelvic health support at home through external vibrational cues that guide correct muscle activation, relaxation, and improved body awareness.

By improving adherence to and effectiveness of recommended pelvic floor training, Pebbla offers a user-friendly and intuitive solution for correct pelvic floor activation and relaxation. This enhances users’ confidence, empowerment, and continuity in training—key factors for successful treatment outcomes. As a home-based medical device with significant potential for commercial scalability, Pebbla contributes to the advancement of accessible and effective health services for women.

The company is currently in the development phase and seeks to build internal competencies related to regulatory requirements and product classification early in the product development process to support informed decision-making and future market access.

3. DESCRIPTION OF THE TASK:

Workshop 1: Regulatory Framework & Product Classification

MDR Assessment: Review of the overall MDR framework and the specific regulatory requirements relevant to pelvic floor training devices.

Medical Device Determination: Competence development in understanding the exact criteria used to determine if the product qualifies as a medical device under the MDR.

Risk Classification: Mapping potential risk classifications and their commercial/regulatory implications.

Vibration Mechanics: Understanding the regulatory impact and specific compliance rules associated with integrating active vibration functionality into an intimate training device.

Workshop 2: Technical Documentation Foundations & GSPR

Technical File Anatomy: Practical competence development within Technical Documentation structure and requirements.

GSPR Mapping: In-depth training on the General Safety and Performance Requirements (GSPR) to identify which criteria apply to Pebbla's hardware concept.

Risk Management Principles: Introduction to risk management methodology and principles (ISO 14971) to translate product hazards into design requirements.

Workshop 3: Clinical, Biological, and Post-Market Evaluation

Clinical Evaluation Requirements: Understanding how to compile and plan the necessary clinical evidence and evaluation pathways for muscle training/biofeedback devices.

Biological Evaluation: Understanding biocompatibility requirements (ISO 10993) relevant to materials with direct skin/mucosa contact.

Post-Market Surveillance (PMS): Planning the future structures required for ongoing market surveillance and proactive safety feedback.

Workshop 4: Regulatory Strategy & Strategic Roadmap

Technical Validation: Assessment of the regulatory pathway to reduce uncertainty regarding future documentation requirements and timeline risks.

The CE Marking Roadmap: Development of a comprehensive overview covering CE marking considerations, documentation milestones, and risk assessment timelines.

EU Market Access: Strategic planning regarding market

Roles and Responsibilities

Clarification of roles and responsibilities within the regulatory process, including requirements related to regulatory compliance and documentation management.

4. TASK OBJECTIVES AND SUCCESS CRITERIA:

The purpose of the project is to strengthen the company’s internal capabilities in understanding, assessing, and strategically managing the regulatory requirements relevant to pelvic floor training devices.

The programme will focus on technical and regulatory validation of the product concept, including classification, documentation requirements, and market access considerations under the MDR framework.

The objective is to enable the company to make informed product development and business decisions at an early stage and reduce regulatory uncertainty prior to future CE-marking activities.

Deliverables

Workshop Material: A complete set of educational slides, standard references, and classification guides customized for Pebbla's product portfolio and relevant risk classes.

Operational Strategy Templates (Google Docs format):

·       A GSPR / Compliance Checklist Skeleton configured for active pelvic floor hardware.

·       A Regulatory Pathway Roadmap Template to track documentation and risk assessment milestones.

Strategic Feedback Session: A dedicated review session where Create Medtech evaluates the team’s initial product classification arguments, initial risk analysis drafts, and proposed clinical approach.

5. BUDGET OG SPECIFICATION OF AN OFFER:  

Total Fixed Price for the Task: 41.000 DKK excluding VAT.

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