Conceptual Design

Conceptual design is an early phase of the design process, in which together with the customer, we use brainstorming methods to conceive the product functunality and   geometry.

the output of this phase is freehand sketches and a requirment specification document.

Detailed design & Prototyping

A prototype is an early sample, model or release of a product built to test a concept or process or to act as a thing to be replicated or learned from.

We design our prototypes to simulate the fuctionality of the product, its planed production process and packeging limitations .

The output of this phase is a CAD files, drawings and a physical model that can be used for proofe of concept(POC).

Test bench and Ex-Vivo trials

A test bench is used to get a preliminary evaluation of functionality, efficacy and safety of the device in the lab, using an artificial environment.

Ex vivo trials are using tissues to perform tests and measurements that would otherwise will not be possible or ethical in living subjects.

We design and build our bench test equipment, or use organs to run the experimental trials in our lab.
The output of this phase is a feasibility trial protocol & report, risk analysis and an updated design

Pre-Clinical Trials

Pre-clinical trials used to evaluate the safety and efficacy of a device on an animal model.
We take part at the protocol writing by defining the technical aspects of the device and its functionality. we produce the devices and participent in the trials.

The output of this phase are verification protocol and report.

Design Transfer

At this phase we work together with the production site to fit the design to the production constraints and methods. We set the machines parameters, write work instructions for manufacturing, assembly and inspection according to ISO 13485 requirments.
The output of this phase is a production validation protocol and report to achieve an approved production line.

Technical Files

A technical file is a set of documents that describes a product and can prove that the product was designed according to ISO 13485.

With support of regulatory expert, we can supply all technical documents : drawings, work instructions,V&V reports and procedures.
The output of this phase is a technical file ready for ISO 13485 application.