In Vitro Diagnostics
The new Regulation is based on a wish to ensure increased safety and quality of In Vitro Diagnostics within the EU.
At Medicologic we are ready and able to assist our clients through the new Regulation, and our consultants are both
experienced and highly skilled within IVDR and CE certification.
Turning Regulation into business
Make sure your product is certified to stay in the market
In 2017 the new “In Vitro Diagnostics Regulation” was adopted – covering the development of diagnostics.
Companies have until May 2022 to meet the new requirements.
At Medicologic we are ready and able to assist our clients through the transition to the new Regulation and the significally increased requirements. Our consultants are both experienced and highly skilled within IVDR and CE certification.
A new Regulation
a notified body.
The new Regulation is based on a wish to ensure increased safety and performance of medical devices that are sold and distributed within the EU.
The new Regulation covers both products already CE marked as medical devices, and with products under development.
Turning Regulation into Business
In order to make sure all business-critical products are permitted to stay in the market, a complete overview of all products and their IVDR-implications could be set up.
Your company could get a clear look at how the regulation translates into business-areas – and all levels of the organization is guided through the process and possibilities.
Planning and execution
We can assist with the planning and execution phases when moving from the existing directive to the new Regulation
– getting the product portfolio ready for the impact.
Keeping the strategy business- focussed
Avoiding legal issues
Ensuring go-to- market for new products
Ensuring market presence
Know-how, skills and mindset
At Medicologic we know all about the challenges of finding talent and the right skill-sets for the tasks.
Medicologic was founded in 2000 by the present CEO Michael Funder, and through more than 20 years we have strived to find the greatest talent and the most skilled specialists for the medical device industry.
Our goal is to create the best scenarios for our clients, and combine our talent and specialists with the goals and budgets at hand.
We strive for customer-service excellence – and a part of this is providing a service, that gives our clients full flexibility to pull on our various ressources on any given time.
The expectations in the medical device market are high with increasing focus on patient safety and treatment methods.
Our team of dedicated freelance consultants and specialists help you develop solutions that meet the expectations, requirements and challenges in the medtech and pharma markets.
Contact
Medicologic A/S
Arne Jacobsens Alle 15-17
DK-2300 København S
Denmark
(+45) 48 24 51 13
contact@medicologic.com
Medicologic-profile
Where to find us
Michael Funder
Owner / Director
(+45) 20 64 41 46
mf@medicologic.com
Lars Bo Andersen
CFO / Administration
(+45) 31 13 51 05
lba@medicologic.com