Archive
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.
18. June 2020
We are a DayOne Accelerator partner!
Innovation in digital health offers a huge opportunity to create true value by improving patient care and clinical outcomes. This, especially in telemedicine, diagnostics, and prevention or early detection. Sharing common missions with the DayOne Accelerator, we are happy to be their partner and support the start-ups of the DayOne Accelerator programm, increase their chances for success and accelerate their time-to market.
DayOne, initiated by a Core Team of volunteering industry experts, medical doctors, tech enthusiasts and researchers, serves a growing community of 2000 healthcare innovators throughout the Basel life sciences and healthcare ecosystem. DayOne is operated by BaselArea.swiss, the office for promoting innovation and inward investment for the cantons of Basel-Stadt, Basel-Landschaft and Jura. DayOne is supported with a special financial contribution by the canton of Basel-Stadt and also by a wide range of knowledge partners and supporting partners.
For more information about Dayone click here
25. May 2020
Postponement of MDR – opportunities, pitfalls and impact on timelines
Now you have the opportunity for MDD submissions, the door has reopened for a moment. This might facilitate your market access. Please find below some answers to the most important questions regarding timelines.
(more…)
16. May 2020
JOIN OUR TEAM! 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 Regulatory Affairs (60-100%)
to join our team.
(more…)
31. March 2020
EU AUTHORISED REPRESENTATIVE – WE ARE READY
If the MDR will be implemented in May this year, it is very likely, that the MRA (Mutual Recognition Agreement) between Switzerland and Europe will not be signed before that date. Therefore, Swiss Med-Tech Companies will need an authorised representative in the EU. Effectum Medical is prepared and can ensure its customers seamless access to the European market.
26. March 2020
MONIKA TRÜMPLER-MÜLLER JOINS EFFECTUM MEDICAL TEAM
We are happy to announce that our team keeps on growing. We would like to welcome Monika Trümpler who has joined us as of March 19th as Marketing & Management Support . Monika looks back to more than 20 years of experience in marketing and administration. We’re glad to welcome her to our team and to count on her support on our marketing and administrative tasks. For more information about Monika please visit her profile on LinkedIn.
24. January 2020
Wir suchen Verstärkung für unser Team
Bist Du interessiert in einem jungen dynamischen Team die Firma aktiv mitzugestalten? Dann suchen wir vielleicht genau Dich!
MitarbeiterIn Administration 40%
(more…)
