We are a full-service clinical research organisation (CRO) specialised in medical devices. We manage clinical trials and conduct strategic consultancy within regulatory affairs, quality assurance and market access and reimbursement.

from Idea
to Revenue

Our Services

We provide strategic consulting services in connection with medical device approval as well as best-in-class expertise within clinical trial management (Qmed is a full service CRO), regulatory affairs, quality management and reimbursement and market access.

Clinical Trial Management

CRO services have played a pivotal role at Qmed Consulting since 2006, encompassing more than 500 successfully completed studies across all device classes.

Pre-market approval studies (worldwide)

Pre-market clinical investigations are meticulously designed and orchestrated to confirm the safety and performance (or efficacy) of medical devices, including clinical claims identified in the Clinical Evaluation process, using pertinent outcome measures.

Post-market approval studies

Post-market clinical investigations are conducted subsequent to the market approval of a medical device. Their purpose is to validate the device's safety and performance (or efficacy) while addressing specific additional inquiries that may arise.

Strategic Consultancy

At Qmed, we provide regulatory affairs and quality assurance services throughout all stages of your medical device projects, starting from the inception of device development to the final product’s market presence.

Our service range encompasses strategic consultancy, technical documentation, quality management, and regulatory compliance, offering a comprehensive suite of solutions tailored to your needs.

Regulatory Compliance

Qmed provides services to ensure your compliance with critical regulatory markets, including EU and US regulations. With our extensive experience across all device classes, we are well-equipped to assist you in meeting regulatory requirements.

Quality Management

Qmed possesses in-house expertise to support you in the development and implementation of a Quality Management System (QMS) that aligns with ISO 13485 and other pertinent regulations and standards.

Clinical Development

Within our Clinical Development department, we bridge the divide between regulatory device requirements and clinical necessities. Our role involves meticulously documenting the process, identifying gaps in Clinical Evaluation documents, and crafting comprehensive materials such as the Clinical Evaluation Plan and Report, as well as other pertinent documents.

Reimbursement and Market Access

Qmed is well-equipped to provide assistance in conducting Reimbursement Analyses, Budget Impact Analyses, and Health Economic Evaluations for your devices across various markets.
Your Trusted Partner for Medical Device Clinical Studies

At Qmed Consulting, we firmly believe that the foundation for the most effective solutions lies in aligning our recommendations and actions with the genuine needs of our clients.

Our primary objective is to complement and enhance your existing expertise and capabilities, rather than supplant them. When you choose to collaborate with us, you can rest assured that we will propose activities that either require additional resources you may not possess, or activities you would prefer to delegate to us. This delegation allows you to allocate your valuable resources to other critical tasks, confident that we are handling the responsibilities entrusted to us with utmost dedication and care.

CRO - Medical Devices

Best-in-class knowledge and expertise from medical device specialists

Our strategic consulting services are built upon the foundation of unparalleled knowledge, experience, and competencies, all sourced from an outcome-driven and deeply motivated team of international medical device strategic advisors, CRO specialists, and reimbursement and market access experts. Within our clinical team, you will find seasoned professionals well-versed in the intricacies of monitoring and designing studies to adhere to ISO14155, FDA CFR and GCP standards.

Our overarching goal is to function as an integral part of the team that paves the path towards successful approvals for innovative medical devices. In doing so, we facilitate more streamlined procedures, enhance patient safety, elevate health outcomes, and enrich the quality of life. Through our efforts, we provide invaluable support to inventors and investors on their journey towards achieving resounding success.

Ready to transit into the new medical device regulation?

This podcast is for you, if you’re facing challenges within all stages of getting a medical device to market. To help you we’ve gathered some of the greatest and most influential minds in the medical device industry, to get their insights on how to go from an idea to a market success.

You’ll be accompanied by our host, Helene Quie, the founder and CEO of Qmed


Keep up with our latest news

Clinical Affairs
Upcoming Changes to ISO 14155:2020
July 9, 2024
Helene Quie

Upcoming Changes to ISO 14155:2020ISO 14155:2020, the international standard for the clinical investigation of medical devices for human subjects, is undergoing significant updates. These changes are designed to enhance risk management, clarify procedures and ensure the safety and efficacy of clinical trials.

Here’s a summary of the key updates:

Risk Management Updates:

1. Risks related to investigational devices (6.2.1)

  • New considerations focus on the specific risks associated with using the investigational device itself. These include adjustments in risk acceptability criteria based on the study population proportion and the updated risk management flow both before and after the start of the study.

2. Risks related to clinical investigations (6.2.2)

  • This section now includes risks associated with procedures required by the Clinical Investigation Plan (CIP) that fall outside standard care. A new section (7.4.5) mandates a risk-based approach to managing these additional clinical procedures, advising sponsors to consider suspending or terminating the study if unacceptable risks arise.

Adverse Event (AE) Categorization
Annex F has been updated to improve the categorization of adverse events (AEs). This includes clear criteria for identifying and classifying serious adverse device effects (SADE), anticipated SADEs, and non-device-related AEs. The flowchart in Annex F has been revised to provide more precise guidance on the categorization process.

Estimands Framework
A new Annex K introduces the concept of “estimands” for clinical investigation design. An estimand is a precise description of the treatment effect that reflects the clinical question posed by the investigation’s objective. This framework helps in aligning the statistical analysis with the clinical objectives, considering factors such as treatment conditions, target population, endpoints, intercurrent events and methods for handling missing data.

Informed Consent
Updates to sections 5.8.1 and 5.8.2 emphasize the importance of obtaining written informed consent from subjects or their legally designated representatives before any clinical investigation procedures are applied. The process must be thoroughly documented, and any special circumstances must be clearly described.

Investigator Brochure
The information required in the Investigator Brochure has been expanded, ensuring comprehensive details about the investigational device are provided. This includes all relevant technical, functional, and clinical performance characteristics.


Clinical Evaluation of Medical Devices under MDR 2017/745
December 20, 2023
Helene Quie

Under the Medical Device Regulation (MDR) 2017/745, the process of clinical evaluation is crucial for demonstrating the safety and performance of medical devices. Qmed’s article likely emphasises the significance of evaluating these aspects and outlines methods to identify and validate safety, performance, and clinical benefits for a particular medical product. Qmed has written an article with the focus on: 1. Importance of Identifying Safety, Performance, and Clinical Benefits. 2. Methods to Identify and Validate Safety, Performance, and Clinical Benefits. 3. How to determining Analytic Methods to Collect Data. Overall, the process of clinical evaluation necessitates a comprehensive approach that involves careful assessment, data collection, analysis, and continuous monitoring to ensure the safety, performance, and clinical benefits of medical devices in compliance with the MDR 2017/745. Hope you enjoy and reach out if you need support to navigate the process!

medical article
Medical Design Control Processes: Where to start! – A top level Overview.
September 18, 2023
Helene Quie

The development and manufacture of medical devices require stringent design control processes to ensure their safety, effectiveness, and compliance with regulatory standards. This white paper provides an in-depth examination of medical design control processes, with a particular focus on the International Organization for Standardization (ISO) 13485 standard, other relevant standards and the Medical Device Regulation (MDR). The paper discusses key concepts, stages, and activities involved in design control, along with the regulatory requirements imposed by the standards and the MDR. By adhering to these standards, medical device manufacturers can streamline their design processes and enhance patient safety and product quality.

Qmed Consulting Newsletter
March 5, 2023
Helene Quie

The year 2023 has come with changes to Qmed! Please help me welcome Agnes Friese Skov as newly announced General Manager for Qmed. At Qmed we are at a journey. The focus is on Qmed clients and the team. Supporting and strengthening the competences and culture Agnes will focus on the well-being of our employees, on our core values and on maintaining a good work culture. I will continue using my experience and know-how to support Qmed existing and future coming customers, and help companies make the right strategic choices for their products in development. With the organisational changes we will support the coming years growth. Thanks Helene

No Approach Fits All Clinical Evaluations.
October 20, 2022
Bassil Akra

Our newest article is a result of an interview by Helene Quie to Bassil Akra, AKRA TEAM’s CEO, on the subject of Clinical Evaluations.

The Use Scientific Surveys as a Method to Collect Medical Device Clinical Evidence
August 3, 2022
Helene Quie, Søren Underbjerg

Our newest article is a result of an interview by Helene Quie to Søren Underbjerg, Qmed Consulting’s Team Lead for Clinical Development and Market Access, on “The Use Scientific Surveys as a Method to Collect Medical Device Clinical Evidence”.