the leading
European
testing laboratory
for cardiovascular
medical devices
the leading
About Us
We are your testing.experts
We at ac.biomed believe that only a responsible business is a successful business. We share the idea of 3e: economically, ecologically and ethically sustainable business is part of our vision to create shared value for business and society.
Testing
We are experts
in what we do
We are biomedical engineers with a strong dedication to cardiovascular devices. ac.biomed is the leading European lab that provides the full range of testing per ISO 5840. We are proud of our methods and our testing equipment, which we have developed and validated ourselves.
From Standard
to Individual
Tailoring the best testing for your application!
We cover almost all cardiovascular devices where fluid interaction is vital:
Arterial Filters Testing
according
ISO 15675
Blood Pump Testing
according to
ASTM F 1841 · ISO 18242 · ISO 14708-5
Cannula Testing
according to
ISO 18193
Cardiotomy Reservoir Testing
according
ISO 15674
Heart Valve Testing
according to
ISO 5840
Oxygenator Testing
according to
ISO 7199 · FDA guidance
Stent Testing
according to
ASTM F 3067 · ISO 25539
Vascular Prostheses Testing
according to
ISO 7198
Individual Testing
Applications
The Tests for Stent
The Tests for Oxygenator
The Tests for Cannula
The Tests for Blood Pump
The Tests for Individual Testing
The Tests for Vascular Prostheses
The Tests for Arterial Filters
The Tests for Cardiotomy Reservoir
Arterial Filters Testing
according to
ISO 15675
according to
ISO 15675
The Tests
- Filtration Efficiency
- Air Handling Performance
- Hemocompatibility
- Structural Integrity
- Regulatory Documentation
Blood Pump Testing
according to
ASTM F 1841 · ISO 18242 · ISO 14708-5
according to
ASTM F 1841 · ISO 18242 · ISO 14708-5
The Tests
- Thrombogenic Potential
- Performance Characterization
Cannula Testing
according to
ISO 18193
according to
ISO 18193
The Tests
- Hydraulic Performance
- Structural Integrity
- Design Validation
- Hemocompatibility
- Regulatory Documentation
Cardiotomy Reservoir Testing
according to
ISO 15674
according to
ISO 15674
The Tests
- Capacity & Flow Performance
- Defoaming Efficiency
- Hemocompatibility
- Structural Integrity
- Regulatory Documentation
Heart Valve Testing
according to
ISO 5840 · FDA Guidance
according to
ISO 5840 · FDA Guidance
The Tests
- All 4 Valve Positions
- Complete Hydrodynamic Testing
- In-vitro and Numerical Flow Field Analysis
Oxygenator Testing
according to
ISO 7199 · FDA guidance
according to
ISO 7199 · FDA guidance
The Tests
- Oxygen Transfer Rates
- Carbon Dioxide Transfer Rates
- Heat Exchanger Performance
Stent Testing
according to
ISO 25539 · ASTM F 3067
according to
ISO 25539 · ASTM F 3067
Vascular Prostheses
according to
ISO 7198
according to
ISO 7198
The Tests
- Mechanical Integrity
- Hemocompatibility
- Flow Performance
- Durability & Aging Studies
- Regulatory Documentation
Individual Testing
Applications
Applications
The Tests
- New Methods
- New Devices
- New Mock Loops
we are biomedical
engineers with a
strong dedication
to cardiovascular
devices
Quality
ac.biomed provides
quality services
We can cover almost all cardiovascular devices where fluid interaction is vital.
We are accredited!
We have implemented our Quality Management to international standards. Our standard laboratory testing and service documentation are certified to ISO 9001 and accredited according to ISO 17025. We have been approved regularly through independent audits.
Our quality processes are standardized so we can use our energy to serve your project.
We value
your products
Our experts provide medical device manufacturers with the best services they need for their products. We are partners for the full life cycle of a new product: the design, international approval, and even production.
Your journey with ac.biomed
Information Phase
1.
Service Request
2.
Information Provision
3.
NDA
4.
Service Requirements
Specification Phase
5.
Service Specification
6.
Quotation
7.
Order
8.
Order Confirmation
Execution Phase
9.
Test Plan
10.
Test Plan Approval
11.
Test Execution
12.
Test Report
we are
independent
the trusted partner
for manufacturers, notified bodies
and authorities
Service
Service around
the world
Our clients are mainly medical device manufacturers from all over the world. They range from audacious startups to global players and market leaders with long and successful histories. ac.biomed has the processes to serve your needs.
Career
Interested in a career at ac.biomed?
We invest in people: ac.biomed welcomes young professionals to develop their perspectives within our international team. We engage in projects with the university to support science and education.