Archive
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.
2025-Plug-Play-QMS-Bootcamp-Effectum-Medical_V1.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.
06. May 2024
Next Plug & Play Bootcamp – Autumn 2024
We are happy to announce the completion of our second QMS Bootcamp with excellent participants and discussions! Thank you and well done to all!
The buzz surrounding our next Bootcamp this Autumn is growing. Now is the perfect time to seize this opportunity and equip yourself and your team with the knowledge and skills needed to navigate the complexities of quality assurance in combination with our proven Plug&Play SOP Packages.
Whether you’re a seasoned professional or new to the field, our Bootcamp offers a comprehensive learning experience tailored to meet the demands of today’s regulatory environment. The bootcamp helps all companies wishing to setup their own Quality Management System and gives you a kick-start when it comes to implementing and configuring the processes to your needs.
Join us this Autumn for our next Plug & Play QMS Bootcamp and take the next step toward ensuring a compliant QMS and the safety
All dates and more information can be found here:
2024-Autumn_Plug-Play-Bootcamp-Effectum-Medical_V1.pdf
05. March 2024
Discover our two podcast episodes with Karina and Nila!
In the first podcast interview with Karina Candrian, you will find out how an impressive company growth of 400% was possible in just a few years. Also find out how our ‘Priority Board’ helps to manage internal processes and how we establish and maintain our company culture.
Spotify: https://lnkd.in/e2CxRMuw
Apple: https://lnkd.in/gXFE2CDF
Google: https://lnkd.in/gp7cRhSi
In the second podcast with Nila-Pia Rähle, it’s all about the ‘healthcare marketplace’. Nila shares insights on how she supports start-ups in getting their products approved and shows ways to bring them to market faster.
Website: www.gesundheitswesen.org
Spotify: https://lnkd.in/etEWtdPi
Apple Podcasts: https://lnkd.in/eHdd6ryF
Soundcloud: https://lnkd.in/eUUDrk6R
19. February 2024
Joint lunch session with Evolution Europe
Accelerate your innovation journey: A (public) funding guide for Swiss start-ups.
In a joint session with Noemí Quesad, Business Development Manager at Evolution Europe, a guide to public funding for Swiss start-ups will be presented. Learn how to accelerate your innovation journey and gain insights into the funding opportunities available for Swiss start-. Join us to gain valuable information and take your start-up to the next level.
📅 March 11, 2024
⏱️ 12-13h
🌐 Online event
Register now for the free lunchtime event and gain insights into financing opportunities for Swiss start-ups.
12. December 2023
Plug & Play (e)QMS Bootcamp – Spring 2024
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, 2024.
2024-Plug-Play-Bootcamp-Effectum-Medical.pdf
03. August 2023
Effectum’s Plug & Play (e)QMS Bootcamp
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 continuously maintained and can be adapted to your needs.
Curious? Then contact us for more information and save your early bird ticket before August, 15th.
2023-Plug-Play-Bootcamp-Effectum-Medical-2.pdf (1893 downloads )
28. February 2023
GREAT TEAM SPIRIT
We believe the secret to enjoy work is also to have fun and laugh as a team. Some of statements we liked most in 2022!
28. February 2023
welcome to the team
Markus Tanner is our new Senior Quality Manager and he joined us in January. Markus brings more than 14 years’ experience from mainly Complaint Handling, Vigilance Reporting, CAPA, HHE, Field Action, Audits, Risk Management and Quality Management Systems (CFR 21 part 820, ISO13485, ISO14971 and MDR).
Markus who is Swiss, lives with his family close to the beautiful Lake Constance. He enjoys family time, sports (skiing & jogging) and reading. Markus is a keen fisherman, but he has realized that instead of improving, the output keeps getting worse by each year.
It’s great to have you on board!
