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Research and IP
Patents and solutions
MedTech // Design · Regulatory · Manufacturing
Your medical device, from idea to market.
Let's Build the Future of MedTech Together
One partner. One pathway. One certified device.
Who we are
Every medical device.
Every medical device.
From idea to certification.
Clustermed designs, develops, validates and certifies medical devices. We turn ideas into certified, market-ready products, with a single partner at your side all the way.
Distinctive expertiseClass III implantable resorbable devices, of animal and polymeric origin
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IIa
IIb
III
Non-invasiveImplantableResorbableAnimal and polymeric origin
4Risk classes
6Regulatory markets
6Steps, one direction
1Partner, turnkey
The pathway
Six steps. One single direction.
Design, regulatory, quality and manufacturing work together from the earliest stages of development.
02
Design
Engineering
03
Validation
Testing and verification
04
Regulatory
Technical File and authorities
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Quality
ISO 13485
06
Manufacturing
Site and process
Distinctive expertise
From non-invasive devices
From non-invasive devices
to implantable resorbable devices.
Devices designed for the people who use them every day: engineered, validated and certified to reach the operating room.
Research and intellectual property
The best solutions,
The best solutions,
with full respect for patents.
- 01 MAPexisting patents and solutions
- 02 CHOOSEthe best routes, free of constraints
- 03 CREATEnew intellectual property
Regulatory
One dossier. Every market.
We know the regulations in depth and deal directly with the regulatory authorities in Europe, the United States, Brazil, Australia, Saudi Arabia and Korea. The quality system is built to ISO 13485.
MDREU 2017/745
FDAUnited States
ANVISABrazil
TGAAustralia
SFDASaudi Arabia
KFDAKorea
Why Clustermed
Four functions. One direction.
A single point of contact
Design, regulatory, quality and manufacturing under one direction, from the first idea to market.
Faster development
Regulatory and manufacturing choices are part of the design from day one, so there are fewer revisions and shorter timelines.
Smart Regulatory
One Technical File built to be reused across markets, while we handle the relationship with the authorities.
Selected partners
Suppliers and consultants chosen to bring every project to a reliable, scalable result.
Your next device
Let's build it together.
Tell us your idea and we will show you how to bring it to market safely, compliantly and efficiently.
Contact us →