Full Service Clinical Research Organisation (CRO) specialised in Medical Devices managing Clinical Trials and conducting Strategic Consultancy within Regulatory Affairs, Quality Assurance and Market Access and Reimbursement.

Enabling
better
health
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, regulatory affairs, quality management and reimbursement and market access.

Clinical trial management

CRO services have been fundamental for Qmed Consulting since 2006, with over 500 completed studies within all device classes.

Pre-market studies

Pre-market clinical Investigation is designed and planned to verify the medical device safety and performance including clinical claims identified in the Clinical Evaluation process as relevant outcome measures.

Post-market studies

Post-market clinical investigation is carried out following market approval of a medical device, and is intended to confirm the safety and performance related to a medical device and answer specific additional questions.

Strategic consulting

Qmed offers Regulatory Affairs and Quality Assurance services during your medical device projects, from initial device development to final product on the market.

Qmed offer a range of services including strategic consulting, technical documents, quality management and regulatory compliance.

Regulatory

Qmed offer services for you to comply with key regulatory markets such as EU and US regulations. Qmed has an extensive experience with various all device classes.

Quality management

Qmed have inhouse capabilities to help you develop and implement a QMS in compliance with ISO 13485 and other relevant regulations and standards.

Clinical development

At the Clinical Development department we cover the gap between the regulatory requirements for devices and the clinical requirement documenting the process and gaps in the Clinical Evaluation documents compiling the Clinical Evaluation Plan and Report and other related documents.

Reimbursement & market access

Qmed can support with the Reimbursement Analyses, Budget Impact Analyses and Health Economic Evaluations for you devices on multiple markets.

Your partner for medical device clinical studies.

At Qmed Consulting we believe that the only way to ensure the best solution for all concerned is to base our recommendations and activities on the real needs of our clients.

Our focus is on supplementing your own expertise and competences, not replacing them.
That means that when you partner with us you can be sure that we will only propose activities for which you either do not have sufficient resources, or that you would prefer us to accept responsibility for in order to free up your own resources for other tasks.

CRO - Medical Devices

Best-in-class knowledge and experience from the medical device experts. (CRO)

We offer strategic consulting services based on best-in-class knowledge, experience and competences from a result-oriented and highly motivated team of international medical device strategic advisors, CRO specialists and reimbursement and market access experts. Our clinical team are experts in monitoring and designing studies to ISO14155 and GCP.

Our purpose is to be part of the team that successfully paves the way for new medical device approvals that enable more efficient procedures while improving patient safety, outcomes and quality of life, thus helping inventors and investors achieve success.

Academy

Please visit our course site regularly, as we will add a new course every month.

This course is tailored for students who wish to have a 1 to 1 session
Helene Quie
€120
Crash course in how to conduct a clinical evaluation according to MDR
Helene Quie
€95
This course is tailored for students who wish to have a 1 to 1 session
Helene Quie
€1209
In this lecture, we will review product material to identify potential claims and possible methods to gather data.
Helene Quie
€120
Identify your device classification according to MDR and US FDA regulation
Merete Hansen
€95
We have pulled together classes and workshops designed to helping companies on their path to enable better health David Rutledge David
David R. Rutledge
€95

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

News

Keep up with our latest news

Clinical Affairs
Medical Design Control Processes: Where to start! – A top level Overview.
September 18, 2023
Helene Quie, CEO at Qmed Consulting A/S

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.

Clinical Affairs
MEDDEV 2.7/1 Rev 4 Clinical Evaluation: Are you ready to update your clinical evaluation report.
April 26, 2023
Helene Quie, CEO at Qmed Consulting A/S

A new version of the European Guideline MEDDEV 2.7/1 rev 4 was issued in June 2016 affecting all companies that market medical devices in Europe. This guidance promotes a common approach to clinical evaluation for medical devices regulated by the directives 93/42/EEC...

Clinical Affairs
Are your sites prepared for FDA inspection of your clinical investigations in EU?
April 26, 2023
Helene Quie, CEO at Qmed Consulting A/S

FDA’s Compliance Program Manual provides Inspectors with instructions for evaluating industry compliance with regulations and Good Clinical Practice (GCP). Among other activities, the FDA Bioresearch Monitoring (BIMO) Program involves site visits to clinical investigators, sponsors, monitors, contract research organizations...

Clinical Affairs
Are your investigator and site ready for an FDA inspection? - Part 2
April 26, 2023
Helene Quie, CEO at Qmed Consulting A/S

FDA’s Compliance Program Manual provides Inspectors with instructions for evaluating industry compliance with regulations and Good Clinical Practice (GCP). Among other activities, the FDA Bioresearch Monitoring (BIMO) Program involves site visits to clinical investigators, sponsors, monitors, contract research organizations, nonclinical (animal) laboratories, and...

Clinical Affairs
The new Medical Device Regulation – and its impact on innovation
April 26, 2023
Helene Quie, CEO at Qmed Consulting A/S

Last week the European commission published the new Medical Device Regulation (MDR) and the question on how this will impact the Medical Device industry within Europe have been asked by many. The purpose of this new regulation is to ensure...

Clinical Affairs
Are you our new CRA?
April 26, 2023
Helene Quie, CEO at Qmed Consulting A/S

Do you have a solid clinical research background? Do you want to drive clinical trials in a company that ensures reliable and thorough approvals for new medical devices? As our new clinical research associate (CRA), you will embark on an exciting and collaborative career...