Accelerate your Medical Device Project
From planning to market access, add extra resources at the right time to hit the market faster. Optimizing every area of your Medtech project!
Our development capabilities
Covering all development phases, whether you are developing a catheter, a sheath or a steerable catheter, you can save weeks off your development timeline.
Concept &
Feasibility
From concept generation, to prototype design, construction and validation.
Design &
Development
Complete design validation testing plans, protocols, test fixture design and tooling, test and reports, transition R&D devices to manufacturing (DHR, DMR, Design transfer)
Risk
Management
Risk management plan and records according to ISO 14971, Design and process FMEA
Design
Verification
Plans, Protocols, test fixture design and manufacturing, test and reports, major testing management (verification, biocompatibility), Design transfer (DHR, DMR)
Validation
Packaging, sterilization, manufacturing Processes, shelf life, Transit, preclinical and clinical trials
Regulatory
Consulting or complete hands-on partners to endorse the CE mark or FDA approval from strategy to market
We gather years of expertise in medtech R&D, clinical expertise, testing, training and manufacturing.
CONSTELLATION is a French consortium of privately held companies located in Strasbourg, France, and 3 stars at the edge of Constellation.
Located in Strasbourg, PROTOMED is a contract service R&D company specialized in medical device design, development and testing. PROTOMED has spun-off its device testing laboratory ProtomedLabs. Its fablab includes prototyping machines (3D printers; CNC machines), test benches, control equipments and state of the art CAD software.
The Institute of Image-Guided Surgery of Strasbourg develops innovative surgery, combining the most advanced minimally invasive techniques and the latest medical imaging methods: two 100-seat amphitheaters with live connection to clinical operating rooms, 17 operating tables, two rooms with the double console da Vinci Si HD robotic system and three hybrid operating rooms.
Created in 2008, by a senior manager in medtech manufacturing, BS-MTI is specialized in the design and production of medical devices. It has an ISO 8 clean room to meet all quality and security requirements that medical devices deserve, and a wide range of expertises in assembly of purge systems, balloon systems, catheters.
Strasbourg has been awarded outstanding environment label by the French Tech initiative, MedTech section. CONSTELLATION is located in NEXTMED, a medtech campus that brings together medical, scientific and industrial skills. Medtronic, GE, Siemens and Karl Storz are already there!
Meet the clinical experts
Whatever the development phase, challenge your product with real life, our experts offer the best advice.
Place where worldwide experts are coming to train others. Meet them in Strasbourg!
Support for preclinical and clinical evaluation, from scientific clinical literature research to acute or chronic preclinical trials
Train your product specialists and team with clinical specialists at the edge of new surgical techniques in wet or dry labs sessions.
Organize a training session with your users in wet labs or come and meet your future users during a regular training session.
Building your marketing positioning with quality and scientific materials and rely on well known experts talks.
State of the art manufacturing facility
From prototype to industrial scale manufacturing.
Our ISO 8 clean room facility to assemble and manufacture devices in a controlled environment
In house Quality Manager to support design dossier development.
Several years of experience in medical device manufacturing. Ability to split device development into several phases and prepare ramp up. Development program conducted under the highest project management standards in the medical device industry.
Custom delivery systems take months to validate. ProtoBrix takes days.
Building a fully custom delivery system before knowing whether your concept even works is a costly bet. Engineering, tooling and manufacturing all happen before you get any real feedback on the design itself.
ProtoBrix flips that order. It is a universal, ready-to-use U-Handle platform that lets you assemble a functional prototype in-house, in minutes, using off-the-shelf components compatible with 6-24 Fr tubes. Validate your concept, gather real test data, and only then commit to custom development — with a much clearer picture of what you actually need.
7 days
to ship
30 min
to assemble
6-24 Fr
tube range
NEED MORE HELP?
Ready to hit the market faster?
Optimizing every area of your Medtech project! Tell us where you are in your development and we add extra resources at the right time.
Medical Device Development Services. Strasbourg, Fr · +33-367-176-720
Copyright (c) All rights reserved. PROTOMED 2026.