MDR- & IVDR-transition

The new Regulation is based on a wish to ensure increased safety and quality of medical devices that are sold and distributed 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 MDR and IVDR.

Successful MDR- and IVDR-Transition

New Regulation, new requirements
In May 2017 the new Medical Device Regulation was adopted – covering both device- and diagnostics-development. Companies have until May 2021 to meet the new requirements – extending the initial transition-period ending at May 2020 with one year due to Covid-19. At Medicologic we are ready and able to assist our clients through the new Regulation and the simnifically increased requirements. Our consultants are both experienced and highly skilled within MDR and IVDR.

A new Regulation

The new Regulation is based on a wish to ensure increased safety and quality 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.

Plan and analyze

We can assist with the initial phase of planning for, how to move from the existing legislature to the new Regulation – and analyzing the impact of the new Regulation on the product portfolio, and get an overview of new and changed requirements through a gap-analysis.

Establish a project group

Once the plan and analysis is in place, and the direction and process is outlined – it’s time to establish the a project group.  The group should a mixture of your own internal ressources and our consultants  The groups single purpose and goal is to implement the new or the changed requirements.

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