Reference projects

A selection of successfully realized projects

The following reference projects provide an overview over the working environment in which we operate.

The filter feature enables you to select the reference projcets by industry sectors or core competencies.

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Equipment Qualification Compressed Air

EXCO qualifies systems and equipment for generating medical compressed air in the hospital environment and validates the process.

Fully automated function tester for PCBs

In order to fulfil highest quality standards in production, EXCO is devloping test stations for blood glucose meters.

Method development for laboratory diagnostics

Biomarkers in point-of-care devices using standardized reaction sequences are verified with a specific method.

Global Product Information System as Web Application

EXCO develops a desktop application for managing product information.

Software for medical test series

EXCO develops a tailored PC software suite to carry out measurement series and studies.

Risk Management and Product Approval

EXCO prepares companies for product audits and evaluates risk management files.

Design verification for a point-of-care device

EXCO provides support in the verification process of a glucose measuring device.

Accompaniment of MDR Product Licensing

EXCO advises a medical device manufacturer on the new European Medical Device Regulation (MDR).

Manual test stations for medical pneumatic valves

EXCO provides support for the modernization of test stations with a complete solution. 

Validation as a Service

EXCO maintains the validity of a client's computerized systems within EXCO's "Validation-as-a-Service" model.

Cleaning validation of production facilities

EXCO develops an analytical method for the quantitative cleaning assessment of a production facility.

Transferring Knowledge between Industry Branches

EXCO develops a supplier to confirmity with the medical industry.

Optical sensors for medical devices

EXCO develops a supplier to confirmity with the medical industry. Valid products and production processes have been established.

Web app for surveillance system

EXCO is your partner for application development to ensure performant and webbased applications.

 

Apps for medical devices

EXCO develops apps for regulated industries such as medical technology. On demand validated.

Demonstration app for medical

Based on the android platform, EXCO develops a mobile app combining real and simulation data for a variety of different application scenarios: testing, training and customer presentation.

MDR Compliance Implant Manufacturer

EXCO ensures compliance with the Medical Device Regulation and supports clients in the transition.

IVDR Compliance

EXCO supports a manufacturer of pre-analytical diagnostic systems on the way to achieving IVDR compliance.

MDR Compliance Implant Medical Products

EXCO ensures compliance with the Medical Device Regulation EU 2017/745 (MDR) and supports and trains clients in the transition.

New QM-system for start-up

For a manufacturer of sterile medical products, EXCO creates a customized QM system according to 13485 and establishes the system within the customer organization.

EXCO Data Analytics: Algorithm development

A medical equipment manufacturer develops a new blood glucose monitor. The measuring procedure must be precise and robust against any errors.

EXCO Data Analytics: Efficient Data Analysis

When developing a new medical device, the client needed support to analyze data.

EXCO Data Analytics: Data Refinement

A client is collecting a wealth of data from various departments (laboratory, production, quality control) for a new product. The client needs support to prepare the data.

Cleaning validation for parenteral nutrition equipment

EXCO ensures that a cleaning system is reliable. To meet highest requirements.

Relocation of laboratories at (bio)medical institutes

In order to ensure the smooth relocation of ten biomedical institutes, EXCO plans and controls preparation and execution of the relocation.

Revalidation of analytical methods

A manufacturer of pharmaceutical products needs a revalidation of analytical methods for the approval of raw materials, after their supplier was changed.

Automation and qualification of an assembly and packaging line

A pharmaceutical manufacturer requests support in order to redesign its production system. Exco supports the commissioning and qualification of an assembly and packaging line.

Cleanroom qualification for cytostatic drug manufacturer

EXCO qualifies the cleanroom and workbenches for a manufacturer of industrially produced, patient specific pharmaceutical infusion solution.

Ensuring conformity of quality documentation and audit preparation

EXCO checks the methods of product release to FDA standards in the analytical laboratory sector. Methods are validated; instruments and appliances are qualified.

Development and validation of an information system for clinical trials

Development and validation of an information management system for suspected cases in clinical trials

Automation of a production system for active ingredients

In close coordination with the site management engineering, EXCO creates the concept for a production systems for active ingredients and takes over the planning of the system automation in collaboration with the system manufacturer.

Development of software for product registration and approval

A client is looking for support in the management of registration and approval procedures for products, which are to be introduced in various regions throughout the world under various conditions.

EXCO is commissioned with the development of software, with which registration procedures can be designed, amended and monitored in a database.

Automation of a test laboratory for highly potent pharmaceuticals

EXCO is to take on the planning of an automation solution, which will control, regulate and visualize the laboratory tests..

Agile software development in rail transport

EXCO develops a data management system used to monitor and survey rail data.

Radiochemical analytics in the controlled area of a nuclear power station

In the course of rebuilding a shut down nuclear power plant the operater seek support: EXCO is assigned to take and analyse liquid samples in the contorll area and conduct a radiochemical analysis.

Development of a vial filling facility

EXCO is supporting a pharmaceutical company in designing a filling system for vials.

Software development for a modified blood glucose meter

We have created the embedded software for a modified blood glucose meter for our clients. This will increase the quality of life for patients.

Verification of embedded software

EXCO is commissioned with the test design, management and completion for verification of the embedden software of a blood glucose meter.

Development and commissioning of test stations

In order to fulfil highest quality standards in production, EXCO is devloping test stations for blood glucose meters.

Product transfer at a medical equipment plant

EXCO is transferring a medical device production system from Austria to Switzerland and ensuring that country-specific legal and licensing standards are met.

Cleanroom qualification

EXCO supports clients as regards qualifying measures in the clean room. From strategic planning to implementation.

Development of a blood glucose meter

A client has modified the hardware of their blood glucose meter. EXCO is supporting the design of the medical device and developing production and test stations.

Equipment evaluation of a new blood glucose meter

EXCO is commissioned to complete electrical and mechanical tests for the conformity evaluation of a blood glucose meter.

Software development - Web solutions

EXCO is designing the software for a REST-based web service.

New control systems for process control technology

EXCO is a reliable partner for process control engineering.

Reverse documentation of PCT - Securing know-how

EXCO has created the reverse documentation for an existing processing chemical plant.

Development of alternative dosing concepts for the application of reagents

EXCO is developing an alternative dosing concept based on a reagent cartridge with an integrated dispensing unit and linear valve control.

Evaluation and qualification of software for analysis systems

EXCO is evaluating and qualifying software for analyzing systems used in lab diagnosis and clinical chemistry.

Fully automated test stations for blood glucose meters

A client is commissioning EXCO with the design and qualification of a fully automated test station.

Safety testing of IVD, laboratory and medical equipment

EXCO is completing the required electrical measurements of devices together with the mechanical tests to ensure conformity to standards.

Gap analysis for existing product files

Gaps have been identified in the documentation of existing product lines. EXCO is creating a requirements list in order to close the gaps. The subsequent TÜV audit has been successfully passed.

Organization of an FDA audit

EXCO is preparing a customer for a pending FDA audit. EXCO is creating a detailed audit plan based on FDA 21 CFR Part 820 requirements and is completing a mock audit.

Meeting requirements

A client is commissioning EXCO with the qualification of test stations and validation of a product line for a blood glucose meter.

Preparation of an EU Declaration of Conformity for a test station

EXCO is commissioned with testing production safety and drawing up the EU conformity declaration.

Migration of a process control system

EXCO offers customized solutions in order to modernize process control systems used in the processing industry.

UDI Implementation

EXCO is validating and testing the Unique Device Identification Database for a client.

Migration of process control systems at existing facilities

Migration of control systems: EXCO automation specialists are updating an existing control system.

Using biological markers

Biomarkers in point-of-care devices using standardized reaction sequences are verified with a specific method.

System engineering for a pharmaceutical manufacturer

EXCO is supporting pharmaceutical companies in designing and qualifying filling systems in their cleanrooms.

Automation for a beverage producer

EXCO is creating the control software used in a filtration system. In order to ensure purity in beverages.

Modernization of an ultrafiltration plant

EXCO is modernizing a filtratrion system and bringing it up to the state of technology.

Automation and documentation

EXCO is updating the software of a test rig and creating the technical documentation.