Product Development

Realising high tech medical products that matter, together

Unlock your Innovation Potential with Technobis

Are you sitting on a groundbreaking idea in the MedTech, PharmaTech, or BioTech industry but struggling to bring it to life? At Technobis, we specialize in transforming theoretical concepts into practical, working designs. Our team of experts in mechanical, electrical, and software engineering is here to guide you through our comprehensive eight-step ISO 13485 certified process.

1. Feasibility

We assess if your idea is feasible, cost-effective, and compliant with industry regulations. This includes a project business plan with design checks, production scope, lead times, and budget implications.

Preliminary BOM
Project Cost overview
Preliminary Risk Analysis

2. Concept Sketch

In close cooperation with you, we produce a first schematic representation of your technical appliance, and if possible, a first 3D model.

Preliminary System Architecture
Concept sketches

3. Requirements

We gather input from end users and stakeholders on your device’s desired features and functionality. This results in a prioritized list of design and user requirements, shaping your final product to be an end user favorite.

User Requirements
System Requirements

4. Development

Technical Development & Engineering Iterations

Our engineers handle the mechanical details, materials, design, ergonomics, and software for your product. They ensure regulatory compliance and produce complete design documentation and Design History Files (DHF).

Hardware & Software Design
Prototypes

5. Documentation

Compiling Compliance Documentation

We compile all necessary documentation for ISO 13485 compliance, including assembly manuals, checklists, acceptance protocols, labeling and packaging instructions, and batch records. This ensures efficient design transfer to production and sets up the device master record (DMR).

Critical Components List
Assembly manuals + checklists
Acceptance protocols
Batch records

6. Pre-Production

Pre-producing Your Product

We build and test your first pre-production device by setting up a supply chain, inspecting parts, preparing the assembly line, and implementing the Factory Acceptance Testing (FAT) protocol. After testing for functionality, endurance, and design, we update the Device Master Record (DMR) with the results.

Final Design Files
Supply chain setup
Production Tooling
0-Series
FAT Tooling + Reporting

7. Certification

Product certification

We provide all necessary documents in the correct order and format for third-party testing and certification. You will receive a pre-production unit for validation and clinical tests, and another for external testing. Your product will then be CE certified or receive the required approval

CE Certification
CSA Certification

8. Series Production

Congratulations! Your design is approved and certified. You’re ready for large-scale production. We’ll update and log all design and manufacturing details, and our assembly lines are set to produce your innovative product!

Series Production
Engineering Change Requests
Cost Optimalizations

Market focus

PharmaTech

We help reduce production costs and increase output of medicine by developing and improving pharmaceutical technology.

BioTech

When you want to make a difference at a molecular level, Technobis helps you develop and improve extreme-precision laboratory equipment.

MedTech

At Technobis, we combine skill, experience, and state-of-the-art facilities to help you create high-precision medical solutions.

Work together?

Multidisciplinary technology

“More than 25 years of innovation, production and partnership”

Systems Engineering
Mechanical Engineering
Software Engineering
Application software development
Embedded software development

Electrical Engineering
Industrial Design
Process development
Certifications CE/CSA
Automated test systems

SOLIDWORKS 3D Modeling & Simulation
SOLIDWORKS Composer Assembly Instructions
MATLAB – Mathematical computing software
Software development: C++/ C Sharp / Python
Azure DevOps

Matrix Requirements – Requirements and Risk Management
Odoo ERP
Engage: E-QMS
Qooling: E-QMS

Client Reviews

What our clients say

For well over 10 years now, Technobis has helped us to develop various type of crystallisation equipment. They successfully created new systems and helped us to improve the design and inner workings for the next generations of our Crystal16, Crystal Breeder, and Crystalline systems. Through close cooperation between the product managers and sales departments of TCS on the one hand, and THS’s team of engineers on the other, we have managed to create a very successful line of products that really fits the needs of our customers.

At Amazec Photonics, we develop a cardiovascular monitoring device, which will make a difference in patient care. Technobis is our partner for the development and series production of this new medical device, by thinking along about optimal functionality, layout and producibility. Technobis helps us to set up a realistic planning, define the Minimal Viable Product and all documents and procedures for the medical certification of the pre-series products.We basically shared our ideas to their development team and by using their engineering insights we will create an optimal medical device together!

Why Technobis?

Benefit from Technobis’ extensive experience in medical equipment design. Our ISO 13485 certification guarantees our expertise. With state-of-the-art facilities and a dedicated team, we offer a one-stop-shop for designing, optimizing, and producing your product, ensuring a successful market launch.

Source code software, firmware
Source files, CAD data
Source files, technical documentation
Patents