Accelerate EU Market Access via Our Legal Manufacturer Framework
Effectum acts as your Swiss-based legal manufacturer — enabling rapid CE-marking under MDR/IVDR with our QMS and Notified Body relationship.
Accelerate EU Market Access via Our Legal Manufacturer Framework
Effectum acts as your Swiss-based legal manufacturer—enabling rapid CE-marking under MDR/IVDR with our QMS and Notified Body relationship.
Outsourced Legal Manufacturer
Need to enter the EU market but lack a certified QMS or local presence? Effectum Medical AG can act as your legal manufacturer. You focus on innovation - we'll take care of regulatory compliance, quality, and audits.
Key Services
- Fast-track MDR/IVDR market entry
- CE-marking under Effectum’s existing QMS
- Notified Body coordination (SGS)
- Vigilance & post-market surveillance
- PRRC services & label ownership
- Manufacturer-of-record role for MedTech and digital health.
When to Choose This Service
- You need speed to market
- You want to postpone building an in-house QMS
- You lack EU legal presence or PRRC capabilities
- Your investors require CE-marking to release funding
Key Benefits
- Accelerated entry: Market devices in months, not years
- Shared responsibility: Offload QMS, audits, and surveillance
- Flexibility: Transition to your own manufacturer role anytime
- Proven Model: model has proven itself for startups, SMEs, and pharma companies
- Swiss-based QMS: Established in Switzerland, centrally located
Unlocking Growth for Startups
The Benefits of Outsourced Legal Manufacturing with Effectum Medical
MedTech startups often face complex regulatory hurdles and high costs. Our new White Paper reveals how outsourcing Legal Manufacturing to Effectum Medical helps overcome these challenges: Faster market entry, reduced costs, and lower risks – all while maintaining full control over your intellectual property. Discover how partnering with a certified expert can bring your innovation to market efficiently.
Download now and gain a competitive edge!
Team LMS | Judith Oriwal
Head of Legal Manufacturing Services
Need a lean and scalable CE-marking path?
Book a consultation with our regulatory leadership team.
What Clients Say
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...
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.
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.”
Klaus Hammer, Head of Regulatory and Quality - Perivision
We received the CE certification benefiting from a "fast track" due to EM’s previous certification history with their notified body. We reached MDR/CE certification approximately 12 months ahead of our time-line, which was a key benefit of our cooperation.
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...
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.