Product Development

Bertrandt Medical turns your ideas into products.

The success of a project depends on the careful consideration of technological, clinical, economic, and legal aspects, and these often overlap. We develop products in a structured and phase-controlled process that is certified according to ISO 13485. This disciplined approach ensures the accurate design and efficient product development of medical devices. You will benefit from our comprehensive know-how and many years of experience in the industry. Our interdisciplinary team will be available to you throughout the entire product development process.

Our services and our development process for designing medical devices focus at an early stage on a clear problem definition and effective risk reduction.  

As the process proceeds, the various design options for medical devices are narrowed down and we arrive at a final product that meets the customer’s requirements and is ready for distribution

Overview of our services

Medical engineering services “made in Germany“

We are specialists in designing medical technology products and we combine electronics, software, and mechanics to produce complex mechatronic systems. From initial design and prototypes to series-production readiness, we create an individual, innovative, and cost-efficient product for you using state-of-the-art 3D CAD software.  

Examples of various services:

  • Mechanical and mechatronic assemblies
  • Technological consulting (plastics/material technology, production processes, etc.)
  • Medical device technology, housing design
  • Jig and fixture construction
  • Precision engineering
  • Actuators, miniature drives, and positioning
  • Simulation (FEM, CFD)
  • Dimensional management
  • Prototype construction / 3D printing

In the field of electronics, our services range from the development of electronic assemblies and sub-systems, analogue and digital measuring circuits, control technology and measured data recording and processing systems to innovative and individual electronics development. Our electronics experts will support you in the following areas throughout the entire product life cycle or in individual process steps:   

Examples of various services:

  • Circuit simulation
  • Inspector software
  • In-circuit testing
  • Prototype PCBs and layout
  • Circuit diagram creation
  • Conformity (CE, ROHS, UL)
  • Individual electronics development

Bertrandt Medical has in-depth knowledge and know-how in the development of medical device software, enabling you to work digitally and achieve the best results. We know that there is no standard, ‘one size fits all’ software solution, which is why we put your needs first and develop your software around your own individual business requirements.     

Our cooperation with leading medical technology and pharmaceutical companies ensures that will you benefit from our relevant industry knowledge: we incorporate market trends, tendencies, and developments that are relevant now and in the future into the development process. In addition to pure software development, if required we can also take responsibility for all the associated processes, such as planning, implementation, software testing, documentation, commissioning, and product support, and we will accompany you through the approval process.

Our software development process complies with the regulatory and normative requirements of the FDA and ICE 62304 for software development and the associated documentation of medical devices.

The Bertrandt development team with its proven specialists in the field of system development offers you many years of experience, valuable expertise, the right methods, and a ‘feel’ for current trends, enabling us to work with you on the products of the future. As an engineering partner with ISO 13485 certification, we can supply you with turnkey systems – reliably and from a single source.

Work together with our project managers to develop the ideal system concept based on your ideas. Our system development team supports your project through the entire life cycle, from checking the determined requirements right through to final approval. Throughout this time, the safety of your product and its conformity will have the highest priority

Project management with Bertrandt Medical means that you can confidently entrust us with the complete task of project control and project leadership.

Our expert consultants, who work either individually or in teams, have all the relevant industry knowledge and experience as well as the skills to make your project a success. They have the leadership qualities to successfully manage teams, have a keen sense for problem solving, and are experts in both conventional and agile project management methods such as Scrum or Design Control.

You can rely at all times on transparent and responsible project execution and communication. One of our project managers will act as a continuous contact person and as an interface between you and our development teams, right from the start and throughout the entire project. Our project management will always focus on your requirements and needs, as well as on ensuring that the process complies with all standards in accordance with the requirements of quality management in medical technology – to ensure your project success!

Your Contact

Kirsten Schild

Head of Bertrandt Medical GmbH