Trusted Partner for MedTech Innovation & Compliance
Effectum Medical streamlines MDR/IVDR certification with regulatory expertise, QMS-as-a-Service & Legal Manufacturer solutions.
ISO 13485 EU MDR/IVDR FDA QMSR/510(k) SaMD/AI-ML Expertise
Your trusted partner for MedTech excellence & compliance.
We make innovation happen!
Effectum Medical streamlines MDR/IVDR certification with regulatory expertise, QMS-as-a-Service & Legal Manufacturer solutions. We are ISO 13485 certified for Medical Devices, Software as a MD, and Invitro-Diagnostics.
Our Services
Outsourced Legal Manufacturer
Launch products under our MDR-certified QMS and reduce your time to market. Includes Notified Body partnerships and fast-track certification.
Plug & Play QMS
Pre-built ISO 13485 / MDR / IVDR / FDA-compliant QMS with SOPs, templates, and on demand cloud-based integration. Ideal for fast execution and internal scaling.
Rent an Expert
On-demand support from Effectum’s senior QA/RA consultants for audits, documentation, QMS setup, or CE marking.
Regulatory Opinions
Get a written expert opinion on classification, applicable standards, and approval roadmap. High value for funding rounds and internal clarity.
Trusted Partner in MedTech Certification
We help MedTech startups and growth-stage companies navigate complex regulatory landscapes. From acting as your Legal Manufacturer to delivering plug-and-play QMS and AI/ ML certification guidance, we ensure compliance while accelerating your time-to-market.
Case Study Highlight: Perivision AG
“Perivision lacked an ISO 13485 QMS and internal regulatory expertise when developing VisionOne. Achieving MDR compliance quickly was critical for market access...”
- Klaus Hammer, Head of Regulatory and Quality -Perivision
OUR CLIENTS
From first certification to global scale - teams choose Effectum for speed and certainty.
Aspivix - Medical device startup -Switzerland
CompagOs - Digital health - Switzerland
Distalmotion - Robotic surgery - Switzerland
Evoleen - Health innovation builder - Switzerland
Guided Clarity - MDR consulting platform - Switzerland
Hemotune - Therapeutic device startup - Switzerland
Hylomorph - Implant technology - Switzerland
machineMD - AI-based neuro ophthalmology - Switzerland
Mika Health - Digital cancer companion - Germany
QUMEA - Patient monitoring systems - Switzerland
Sleepiz - Contactless sleep monitoring - Switzerland
Tuneful - Digital audiology - Switzerland
YLAH - Autism therapy digital support - Germany
Zurich Soft Robotics - Medical robotics - Switzerland
Felix Schmidt, CEO - Deep Breath Intelligence (DBI)
The speed to market was significantly accelerated thanks to EM's QMS, which is fully compliant with EN ISO 13485, MDR/IVDR, and FDA requirements.
Thomas Fünfschilling, U-Sana Medical
When we founded our company, it was during the peak season for MDR, and all notified bodies were overwhelmed with transitioning their existing clients and products to MDR...
Dr. Anjali Raja Beharelle, Co-Founder at Collabree AG
In general, the QMS documents offer excellent guidance and reflect best practices across the board. The system validation was already completed by Effectum, which saved us a lot of time and effort.
Emanuela Pufe - Fusi, Head of mediQ (PDAG)
EM offered us the one-stop-solution we were seeking for. It is the combination of QM infrastructure and advisory capacity what makes them unique. Overall, it is a very satisfying collaboration for us, and we have not been disappointed.”
Felix Schmidt, CEO - Deep Breath Intelligence (DBI)
The speed to market was significantly accelerated thanks to EM's QMS, which is fully compliant with EN ISO 13485, MDR/IVDR, and FDA requirements.
Thomas Fünfschilling, U-Sana Medical
When we founded our company, it was during the peak season for MDR, and all notified bodies were overwhelmed with transitioning their existing clients and products to MDR...