Enabling better health
from idea to revenue

Transform your ideas into revenue with a wide range of worldwide strategic services and support for medical device and IVD companies.

Asset 1
Certifikat logoer

*CQMS is ISO 14155:2020 and ISO 9001:2015 certified

Our services

We provide full-service medical device
CRO services to people

Test

Your partner for medical device clinical research.

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.

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

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 commercial healthcare 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.

Qmed consulting

Podcasts

The Qmed Podcast

Season 2 Ep. 9 with Richard Houlihan

The Qmed Podcast

Richard joined us on a previous episode back in 2019 where he explained basic fundament behind the EUDAMED database. Since then, a lot has happened with the database and in this episode, Richard will provide an overview and explanation of the recent updates and changes to the platform.

Learn from us

Qmed Academy

Bg writing

How to define and demonstrate medical device product claims?

How to define and demonstrate medical device product claims?
Helene quie
Helene Quie
€ 95
Sd

Having troubles conducting you Benefit – Risk analysis?

We have pulled together classes and workshops designed to helping companies on their path to enable better health David Rutledge David
David rutledge
David Rutledge
€ 95
Download

Identify your device classification according to MDR and US FDA

Identify your device classification according to MDR and US FDA regulation
Merete hansen
Merete Hansen
€ 95
Download

1:1 Identify your claims

In this lecture, we will review product material to identify potential claims and possible methods to gather data.
Helene quie
Helene Quie
€ 120
Bg book laptop

1:1 Device Classification

This course is tailored for students who wish to have a 1 to 1 session
Helene quie
Helene Quie
€ 120
Bg cappucino setup

Crash course in how to conduct a clinical evaluation according to MDR

Crash course in how to conduct a clinical evaluation according to MDR
Helene quie
Helene Quie
€ 95

News

Keep up with the latest news

News from the UK
The transition period for the United Kingdom to leave the European Union is coming to an end on 31 December 2020. After the deadline UK will be considered a third country if no...
News from Switzerland
In Switzerland, just as elsewhere, ‘Europe’ and immigration are closely connected topics. The right wing political party is very vocal in its campaigning to reduce the numbers o...
NEW – The Qmed Academy Book Club
Important new MDCG guidelines are released from the European Commission...
How to Spend the Time
Several guidance’s, posts, webinars have been published addressing what...

Management

Your trusted partner

Qmed Consulting is a trusted partner to Top 40 medical device companies and global CROs since its establishment in 2006

Logo1
Logo2
Logo3
Logo4

Helene Quie

Chief Executive Officer, Owner and Senior Principal Advisor

Helene Quie has a degree in Science specialised within cellbiology from the University of Odense. Helene has 20 years of experience within the pharma and medical device industries working for inter alia Cook Medical A/S, H. Lundbeck A/S, AMBU A/S and Millimed A/S. Her primary expertise is within the clinical and regulatory areas such as device development, quality management, project management, clinical trial execution, market access and general management. In 2006 she founded Qmed Consulting as a private consultancy company providing services within medical device development and clinical trials.

Stephanie John

VP of Clinical Affairs and Clinical Senior Principal Advisor

Stephanie John has 17 years of experience within the Medical Device Industry. She holds a PhD in Microbiology from the University of Manchester and has worked for both CROs and medical device start-up companies in the field of Clinical and Regulatory.

Her previous work includes cardiovascular surgery, vascular surgery, interventional cardiology, interventional neuro radiology, middle ear implants (active implantable), intensive care studies, gynaecology and orthopaedics. She speaks French and German on a daily basis.

Mikael Møller

Chief Financial Officer, Human Resource, Legal and IT
Mikael Møller holds a Graduate Diploma in Business Administration HD(R) from Copenhagen Business School. He’s also a Certified Accountant and has worked as such for almost 20 years with focus on Economic Management, primarily for SME’s. Since 2006 he has acquired broad competences as Finance Manager, Chief Financial Officer and Board Member within different areas such as City Development Consultants, IT Services, Public Transportation and now the Medical Device Industry.