IVDR report reveals pain points IVD companies are currently facing

We are delighted to present the results of our market survey “IVDR-Readiness-Survey-Report-March” which was conducted end of 2020 together with our partner Expand Healthcare.

IVDR-Readiness-Survey-Report-March-2021-1.pdf (206 downloads )

The aim was to

gain insights where companies stand with regards to IVDR implementation
understand which threats and challenges they are facing
how IVDR challenges can be solved

Effectum Medical’s passion is TO BE CLOSE TO YOUR INNOVATION AND bring it to market.

23. February 2021

From Uganda to Effectum Medical!

Please join us in welcoming Markus Stohler to the team as our new Head of Supply Chain Operations.

Markus has a background in Mechanical Engineering and a Master’s in Medical Technology and we are looking forward to benefiting from his international experience in Supply Chain Management, Manufacturing Technologies, Process Validation and Risk Management.

For more information about Markus please visit his LinkedIn profile.

25. November 2020

Upcoming event of our partner BioLAGO

We are delighted that Karina Candrian is invited to speak at the upcoming event of our partner BioLAGO: Der Countdown läuft: IVDR, MDR, und Vigilanz jetzt richtig umsetzen.

If you did not register yet for Dec. 4, but you would like to stay up to date about MDR/IVDR and change knowledge with like-minded, then the event is right for you.

06. October 2020

Are you well prepared for the new IVDR?

The new IVDR, coming into force on May 2022, will have major implications on your operations. The need of a notified body for app. 80% of products, even for existing ones, and the assignment of a Person Responsible for Regulatory Compliance (PRRC) are only some of them. (more…)

29. September 2020

Workshop: Introduction to product developement and regulatory affairs

Do you want to understand how product development and regulatory affairs (MDR/IVDR) need to work together to successfully bring products to market?

If the answer is a ‘yes’, this workshop by Nila-Pia Rähle is for you. The course will provide participants with an overview of the regulatory landscape for medical devices in Europe (MDR/IVDR) and will also touch upon different aspects for the US market. Participants will get a good understanding of the product development process, as well as the requirements regarding technical documentation.

24. September 2020

Workshop: Bringing your project to success while mastering the challenges of IVDR (in-vitro diagnostics)

The goal of this workshop is to give an overview of the regulatory landscape for in- vitro diagnostics medical devices in Europe (IVDR), the product development process, as well as the requirements regarding technical documentation. Within the IVDR the workshop will focus on the development of medical devices and software.

(more…)

31. August 2020

Regulatory online-workshop for start-ups from medical device industry

Are you confident with the regulatory landscape of MDR? Do you know the product development process for medical devices and software? Do you have a thorough understanding of the requirements for technical documentations? If you tend to response with “no” our workshop is tailored to you.

The 2 hours session (2-4 pm) on Sept 17th is free for start-ups, as we from Effectum Medical like to support innovation.

For more information: click here

or just register by sending an e-mail to workshops@effectummedical.com.

Looking forward to welcome you.

Your Effectum Medical Team

19. August 2020

We are hiring!

Effectum Medical is a young company that is breaking new ground in the areas of quality management and regulatory affairs in the medical device industry. Our vision is to facilitate and accelerate medical device product innovation by offering an affordable, outsourced quality management system (QMS) and legal manufacturing. Our customers are start-ups, as well as global medical device manufacturers.

To further grow our company, we are looking for a

Project Manager Medical Devices 80-100%

to join our team.

(more…)

18. August 2020

Congratulations to our Notified Body DQS

Congratulations to our Notified Body DQS, who has recently been MDR accredited! Within the EU there are only 16 Notified Bodies according to MDR and we are very pleased that DQS is one of them.

This is also an important milestone for Effectum Medical. To meet our customers interest we are optimally prepared for the introduction of the new MDR in 2021. We are excited to be ready for the next step of our journey!

For more information click here

17. August 2020

Julia Enders welcome to our team!

She will support us in regulatory affairs projects. We are pleased to have found such a cheerful and competent person with experience in regulatory affairs for medical software and wish her a good start.

For more information about Julia please visit his profile on LinkedIn .

Archive

25. March 2021