Medical Device Development

Making your product idea market ready

Grasp

Experience

Commitment

Developing Medical Products

The development of a medical product is demanding and complex. Are you interested in a trusting collaboration? Then you are right here. TEQABLE has in-depth know-how and knows the necessary processes and security requirements.

Step 1

Intended Use

The clear definition of the intended use is the starting point of a medical product development. The requirements and specifications are derived from this and the medical classification is made, which sets the guidelines for development.

Step 2

Requirements and continuous Testing

Right from the start, we focus on the safety requirements according to the classification and use proven approaches and methods. Together with you and a network of partners, we establish the requirements for the product, laboratory tests and clinical evaluations. Testing is key.Testen ist das A und O.

Step 3

Software and System Development

Development takes place in interdisciplinary teams who ensure that the regulatory and safety-related requirements as well as the functionality and usability are met. In addition, even with medical products, achieving the target costs is a demanding task that accompanies the entire development period.

Step 4

Risk assessment and Validation

For a medical product, the personal risks must be reduced to the bare minimum. A risk analysis is initiated at the beginning of development, options for the mitigation of risks are shown and these are implemented and tested in every step. Clinical studies are carried out during the validation to demonstrate performance.

«Feasible, tangible, TEQABLE – engineering success!»

Our competencies

Get to know us within a day

In an innovation workshop with you, we will find two to three solutions that work.

In a moderated risk analysis, we work with you to develop an initial FMEA.

Engineering

Methodologies & Processes

Medical Device Development Requests

Get in touch with us and let us advise you on the implementation of your product idea without obligation.

Get experts on board! – Together we succeed.

We share our wealth of experience with you and you share the responsibility for product development with us. This is how we achieve market entry together step by step.