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Quality assurance, automation and development

Precautionary measures taken at EXCO
  • Strict protective measures
  • Mobile working
  • Reporting requirement
  • Workplace and travel restrictions

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As a global technical service provider, EXCO provides quality assurance measures, plans and realises test, manufacturing and production processes and develops software and system solutions.

We support your development activities with innovative solutions and ensure quality standards and deadlines.

This allows you to retain your complete flexibility.

 

 

 

 

The EXCO Portfolio

MDR / IVDR Compliance

MDR / IVDR Compliance
  • Technical Documentation as a Service
  • Pre-Compliance-Test
  • Managed Product Care
  • Managed MDR/IVDR Transfer
  • Supplier Management

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Data Analytics & AI

Data Analytics
  • Data Analytics
  • Machine Learning and AI
  • Data Linking for Smart Data
  • Predictive Maintenance

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Process Control & Compliance

Process Control
  • Main Automation and Validation Vendor (MAV²)
  • Industrial Automation and IT Solutions
  • GxP Compliance Consulting & Validation Services
  • Smart Operations Support Services

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Digital Factory

Digital Factory
  • Digitalization and Industry 4.0
  • Augmented Digital Operations
  • Autonomous Digital Systems
  • Mobile Data Management

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Agile App Development

Agile App Development
  • Web, Mobile & Desktop Applications
  • Client/Server, Database and Cloud Solutions
  • Requirements Engineering, UX and Wireframing
  • Full Stack Development
  • DevOps, Agile Development

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Automated Inspection Systems

Automated Inspection Systems
  • Functional Test Stations (ICT, FCT)
  • Inline Test Handlers
  • Optical Inspection Systems (OI)
  • In-System Programming (ISP)
  • Acceptance Test Stations (ATP)

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Scientific Services

Scientific Services
  • Laboratory Analytics
  • Development Analytical Methods
  • Qualification & Validation
  • Clinical Trials

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Quality Solutions

Quality Solutions
  • Quality Management Consulting
  • Testing
  • Product Submission
  • Safety & Security
  • CSV

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Individual Training Services

Individual Training Services
  • Certified Trainings
    (ISTQB, IREB, ASQF, ICPMSB)
  • GxP Training and Coaching
  • In-House Training
  • Training Management as a Service
  • Webinars and Online Training

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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.

Equipment quailfication medical compressed air

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

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.

We will successfully complete your projects

A selection of projects that have been successfully completed for our B2B clients highlight to you how we work. Take advantage of the experience of our project managers. We will explain our procedures to you using specific project examples. We focus on success and results in all that we do.

So that you can optimize your time, resources and costs.

To enable you to save valuable time, resources and cost.

Medical Engineering Industry

“From a single source”


As a technical service provider, EXCO develops the software embedded in a medical product as well as the testing stations used in production.
This increases the quality of life for patients as a result.

Biotechnology Industry

“For secure diagnoses”


In point-of-care equipment, biomarkers should be proven with a specific method through standardised reaction procedures. EXCO develops and validates the methods to prove biomarkers with a specific method through standardised reaction procedures.
As a result, illnesses are recognised more quickly.

All references

“Customised solutions”

An extract of reference projects shows that we provide our solutions to focus on our clients and their results.

This means our customers reach their aim more quickly.

Offene Stellen

EXCO GmbH

Offene Stellen

EXCO PCC GmbH

Offene Stellen

EXCO Consulting GmbH

We are looking for people who have the courage to make things happen

Would you like to change? We’re happy to explain the career options at EXCO to you. Diverse opportunities, interesting projects and challenging tasks await you. Your work will prepare the ground for innovation in SMEs and for renowned business clients. EXCO has the job that suits you.

Apply to us!

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EXCO Wissen - geteilt mit unseren Kunden

Aktuelle Entwicklungen und Branchennews zu Themen der Medizintechnik, Entwicklung von Medizinprodukten, Design-  und Hardwareverfizierung, Entwicklung und Qualifizierung Prüfsysteme, Qualifizierung von Fertigungsanlagen, Qualifizierung von Analysegeräten, Klinische Studien und Computer System Validation, Pharmatechnologie und Spannendes aus den regulierten Industrien.

Wo führt die Reise hin? Der EXCO-Blog zeigt Wege auf...

Expert contact

Stephan Blab

T+49 6233 73778-120


EXCO-Blog: Neuster Beitrag

FDA publiziert überarbeiteten MDSAP Leitfaden zur Auditierung

Header-EXCO-Kernkompetenzen-Ingenieurdienstleister-Consulting

Das Dokument MDSAP AU P0002.005 Audit Approach enthält spezifische Anweisungen zum Durchführen von Audits im Rahmen des MDSAP-Programms. Es enthält einen Audit Ablauf, Anweisungen zum Prüfen jedes spezifischen MDSAP-Prozesses und identifiziert Links, die die Interaktionen zwischen den Prozessen hervorheben.

Leitfaden Konfigurationsmanagement angepasst

Header-EXCO-Kernkompetenzen-Ingenieurdienstleister-Consulting

Die Deutschen Fassung DIN ISO 10007:2020-10 "Qualitätsmanagement - Leitfaden für Konfigurationsmanagement" zum internationalen Standard ISO 10007:2017 “Quality management - Guidelines for configuration management” ist seit kurzem vorab bereitgestellt. Inzwischen wird die Anwendung des Konfigurationsmanagements von diversen Qualitätsmanagementsystemen gefordert, nicht nur in der Luft- und Raumfahrtindustrie, sondern auch in der Automobilindustrie oder Medizintechnik.

Genauigkeit von Messverfahren

Header-EXCO-Kernkompetenzen-Ingenieurdienstleister-Consulting

Der Entwurf der Deutschen Fassung DIN ISO 5725-2:2020-10 zum internationalen Standard ISO 5725-2:2019 “Accuracy (trueness and precision) of measurement methods and results — Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method” ist seit heute publiziert.

Veröffentlichung der Durchführungsverordnung

Was regelt die Common Specification für die Wiederaufbereitung von Einweggeräten? Wichtiges zur Durchführungsverordnung (EU) 2020/1207 zur Wiederaufbereitung und weiteren Wiederverwendung von Medizinprodukten zum Einmalgebrauch in einer Gesundheitseinrichtung.

MDR-Update: Das Wichtigste im Überblick

Gemäß der neuen europäischen Verordnung über Medizinprodukte (MDR) gibt es neue und überarbeitete Regeln für die Zuordnung von Medizinprodukten zu ihren Produktklassen. Was hat sich geändert und welche Folgen hat das für Hersteller?