News
10. February 2025
New report alert: Unlock the €498bn German healthcare market
We had the opportunity to review the latest report from EIT Health, and we’re proud to have contributed to this important work. Thank you to EIT Health for trusting us with this task. It’s been great to support such a valuable initiative that drives innovation and progress in healthcare across Europe.
EIT Health is proud to launch “MedTech and Digital Health: A Comprehensive Guide to Market Access in Germany”. This essential guide offers European healthcare start-ups actionable insights to navigate Germany’s complex regulatory landscape and seize opportunities in Europe’s largest healthcare market.
What’s inside?
Tips for regulatory success, including MDR & CE certification.
A guide to Germany’s reimbursement pathways (DiGA, SHI, PHI).
Proven market entry strategies, drawn from real-world success stories.
Whether you’re just starting out or planning to expand, this guide equips you to unlock Europe’s largest healthcare market.
Download it now and accelerate your market entry: https://loom.ly/Nse1-fM
Stay tuned for more reports to empower your MedTech and digital health journey across Europe.
14. January 2025
New opportunity – Medical Device Expert Software 80 -100%
We are currently looking for a
Medical Device Expert Software (80-100%)
to join our team.
In this position you
- Your primary focus will be on projects involving medical software and active medical devices/IVDs with embedded software across all risk classes.
- You will collaborate with customers, ranging from start-ups to teams within global corporations, to refine their technical documentation to meet the requirements for CE marking or FDA approval.
- Your responsibilities will include reviewing, approving, and contributing to the establishment of technical documentation. (more…)
05. December 2024
QMS Plug & Play Bootcamp Spring 2025
Are you a medical device start-up and the topic of quality management system (QMS) gives you more stress than pleasure? Do you associate with QMS a lot of work that is not really part of your core competence but a necessary evil of your venture?
Then this workshop is just right for you. In our modular and hybrid bootcamp, you will acquire an ISO 13485 QMS, which is continuously maintained and can be adapted to your needs.
Curious? Then contact us for more information and save your early bird ticket before January 31st, 2025.
Attention: New Deadline!
The new registration deadline is February 14, 2025.
2025-Plug-Play-QMS-Bootcamp-Effectum-Medical_V2.pdf
26. November 2024
CE-Certified Smartphone Blood Pressure Monitoring by Swiss Company Biospectal
Case Study Biospectal
Swiss start-up Biospectal has introduced OptiBP™, an innovative smartphone app for blood pressure monitoring. Users can measure their blood pressure quickly and conveniently in just 30 seconds by placing their fingertip on the smartphone camera. Developed in collaboration with the Swiss innovation hub CSEM, the technology uses optical biosensing and AI algorithms and meets the strict CE EU-MDR certification standards.
Key Benefits of the App:
- Accurate, user-friendly blood pressure monitoring anytime, anywhere.
- Quick and easy sharing of results with doctors and family members.
- Avoids stress-related inaccuracies caused by the “white coat syndrome.”
Background:
Hypertension affects 1.3 billion people globally and is a leading contributor to heart disease, the most common cause of death worldwide. The app aims to improve early detection and management, reducing health and economic burdens. According to WHO, targeted hypertension management programs are among the most cost-effective healthcare measures.
Technology and Development:
OptiBP is based on over 15 years of research and more than two million clinical measurements. Its accuracy has been validated globally in studies conducted in Switzerland, Belgium, and low-resource settings, with support from organizations like the Bill and Melinda Gates Foundation.
Future Plans:
Following its launch in Switzerland, Biospectal plans to expand to other European and global markets.
Founded in 2017 and headquartered in Lausanne, Biospectal aims to revolutionize blood pressure monitoring. CSEM, a key partner in the technology’s development, is a renowned innovation center focused on creating impactful technologies for society.
24. May 2024
Listed as a Top 9 Medical Device Consulting Firm of 2024 by Qualio!
We are delighted to have been listed as one of the 9 top medical device consulting firms of 2024. You can find the article here
Contact us to learn more about Effectum’s activities and how we can support you as legal manufacturer of your product, as consultants or in setting up your own QMS with our SOP packages.
