Product Development
We help you develop your ground-breaking technological idea for the BioTech, Pharmatech, or MedTech industries into a workable, sustainable design that can be produced on a bigger scale.
Fine-Tuning Your Ideas
Say, you’ve developed a technical idea that will greatly improve production and working methods in the MedTech, PharmaTech or BioTech industry. Your piece of technology works wonders in theory, but you cannot find the means to test it, and polish it into its optimal shape.
If this is your story, you’ve come to the right place.
At Technobis, we specialise in mechanical, electrical, and software engineering for the medical industry. We are happy to help you explore your idea and turn it into a working design, by guiding you through eight steps.
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Eight Steps to Industry Staple
Your innovation may have the potential to become a standard within the world of medicine. In order to reach that status, however, it needs to be developed, and tested rigorously. At Technobis, you can call on our expert knowledge to help you make your technical advancement a daily reality, benefiting healthcare professionals around the world. We follow eight steps to help you make it happen:
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Feasibility Assessment
In this first phase, we explore whether it is feasible that your idea can be developed in a cost-effective manner, and whether it can be made compliant with industry regulations and requirements. We draw up a project business plan containing design checks, production scope and lead times, and budget ramifications.
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First Schematics & Concepts
In close cooperation with you, we produce a first schematic representation of your technical appliance, and if possible, a first 3D model.
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Feature & Functionality Wishlist
Together with you, we ask your possible end users and stakeholders what they think your device should be able to do. It’s modules, characteristics, properties, and operational behaviour. This gives us a list of design and user requirements, which we will order by priority. The resulting requirements document not only helps shape your final product, it makes it an end user favourite.
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Pre-producing Your Product
This is where we build and test your first pre-production device. To do that, we will set up a supply chain, order and inspect the necessary parts, prepare our assembly line, and implement the Factory Acceptance Testing protocol (FAT). Aftér your first pre-production devices have been built, we will test them for their functionalities, endurance, and design choices. We will then update all relevant design and manufacturing information in the Device Master Record (DMR) based on the outcomes of our first production.
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Compiling Compliance Documentation
In this step, we compile all the documentation you need to comply to ISO 13485 industry standards. This includes assembly manuals, checklists, acceptance protocols, labelling and packaging instructions, and batch records to be able to track your device’s components. This helps us efficiently transfer your design to our production department and set up the device master record (DMR).
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Technical Development & Engineering
Our engineers work out the mechanical details of your product. They think about optimal internal product lay-out, as well as your product’s choice of materials, shape, design, and ergonomics. They also write the operating software and the interface through which the end user will control the final product. Throughout the process, we keep a close eye on all regulatory requirements. The resulting output are complete design documentation and Design History Files (DHF).
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Product Certification
We make sure you receive all the required documents in the right order and formatting. This helps you let an official third party test your product, and meet all the requirements to safely apply for certification. We will also send you a pre-production unit, which can be used for validation and clinical tests. You can send another pre-production unit for testing by an external party, testhouse for EMC/LV, or Notified Body. Your product is now officially your CE certified Intellectual Property (IP), or has received any other type or approval required.
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Producing Your Product in Series
Congratulations! Your design has been approved and certified. You are now ready to start producing your piece of equipment on a bigger scale. We will update and log all relevant design and manufacturing details in your documentation. Our assembly lines are ready to start producing your innovative product!
Why Technobis?
With Technobis, you can benefit from our longstanding history in updating and upgrading medical equipment designs. Our ISO 13485 certification is your guarantee of our expertise. Making full use of our state-of-the-art facilities, our dedicated team forms a one-stop-shop for designing, optimising, and producing your product. To help you launch your idea onto the market in the most effective manner!
- We develop your Intellectual Property (IP)
- Source code software, firmware
- Source files, CAD data
- Source files, technical documentation
- Patents
From initial idea to intellectual property, Technobis is your safest path. Take your first step and contact us today.
Market focus
We help reduce production costs and increase output of medicine by developing and improving pharmaceutical technology.
When you want to make a difference at a molecular level, Technobis helps you develop and improve extreme-precision laboratory equipment.
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”
- Skills
- Systems Engineering
- Mechanical Engineering
- Software Engineering
- Application software development
- Embedded software development
- Electrical Engineering
- Industrial Design
- Process development
- Certifications CE/CSA
- Automated test systems
- Tools
- 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
