Menu
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.
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.
CRO services have been fundamental for Qmed Consulting since 2006, with over 500 completed studies within all device classes.
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.
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.
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.
Please visit our course site regularly, as we will add a new course every month.
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
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.
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...
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...
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...
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...
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...
We’re looking forward to hearing from you!
If you have a question or require assistance
please feel free to contact us.
Qmed Consulting is a trusted partner to Top 40 medical device companies and global CROs since its establishment in 2006
Koebmagergade 53, 1.
DK-1150 Copenhagen K.
+45 56 64 10 10
info@qmed-consulting.com
Proud sponsors of
Red Cross and Mothers Aid.
Qmed Consulting is an ISO 9001:2015
& 14155:2020 certified company.
