Medical devices consulting
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Rob Stijlen
Rob Stijlen

Business Applications for medical device companies in the medium‐sized business sector

We understand your processes. And increase your efficiency.

Big Data, Cloud Computing, Digital Transformation and Mobile Applications – for over 18 years, ARCONDIS has been supporting medium‐sized companies (SMEs) in the design of modern, compliant processes with perfectly tailored business applications: from the selection and definition to the integration in your everyday business.

This support ranges from research and development to engineering and technical documentation to regulatory affairs and commercial operations. It also spans from coordinated strategies to agile process design to efficiently used technology.

Medical technology expertise along with our experience with medium‐sized companies guarantee that we implement even your most complex requirements in practical business applications that grow with your Company. In solutions that are perfectly tailored to your requirements as a medical device manufacturer and that are 100% GxP‐compliant. We not only ensure a high level of acceptance among your business customers, but also guarantee flexible capacities, an efficient cost control and the maintainability by your IT.

From strategy to implementation
– everything from a single source.

First‐class concepts and strategies alone do not offer you any added value.

That is why we implement them for you in one step from A to Z. Our consulting work is only done once the results are achieved in your everyday work and the transfer of expertise to you has been completed. In this way, we protect your financial capacities and secure your return on investment!

For all of these reasons, three of the five largest medical technology companies, among others, have been relying on our consulting expertise for many years.

Do you want to learn more about the topic of “business applications in medium‐sized medical device companies”? Then please get in touch with us at one of our Locations!

Our Services

With more than 300 successful validations in 14 years, we offer compliance made to order, without unnecessary padding – from the framework to concrete validation and from laboratory system to ERP to cloud‐based CRM.

Your benefits

  • High audit security with overhead‐optimized implementation through our experienced validation experts
  • Compliance over the entire life cycle of the application due to reusable, simply expandable documentation
  • Quicker time to market through lean, risk‐based validation

CSV Frameworks

Validated Clouds

Validation of Life Sciences specific Business Solutions

Validation of Enterprise Solutions (ERP, Excel…)

CSV Trainings

As a supplier‐independent consultant, we have accompanied our customers through more than 100 projects in selecting the optimal support for their business processes, and in implementing and anchoring these in the organization through our excellent knowledge of the current software market and a transparent evaluation methodology. From requirements analysis to management during operation.

 

Your Benefits

  • Investment protection through make‐or‐buy decision templates
  • Optimal added value for your business as a result of a proven and transparent selection process that takes technical departments and users into account
  • Consideration of integration capability into customer‐specific information landscapes, particularly into validated environments

Requirements Engineering

Tool & Vendor Evaluation

Software Implementation

IT Application Management

In more than 125 projects we have significantly increased the business fit, usability and stakeholder acceptance of inhouse developments, industry solutions and combined products in the areas of research, development, regulatory affairs and commercial operations with intelligent requirements Engineering.

Your Benefits

  • Guaranteed business suitability of the solution thanks to certified IT requirements engineers with life sciences background
  • Faster time to market by avoiding scope creep
  • Higher acceptance through target group‐specific stakeholder management
  • Project cost reduction through structured evaluation and prioritization of requirements

In all our projects we combine our life sciences know‐how and modern change management methods, thereby ensuring rapid and reliable integration of the solution in your organization: from an individual project initiative to global organizational changes.

Your Benefits

  • Quicker and higher acceptance of new solutions by technical departments and users with the aid of the “People‐Centred Implementation” approach (PCI®)
  • Active and sustainable management thanks to a change management PMO with certified change consultants
  • Proof of success of measures by means of a quantifiable change curve and proven KPIs

Strategic OCM

Operational OCM

Communication Management

Training Management

Competent and intelligent project management is our passion. We have successfully implemented over 400 project management mandates in the areas of research, development, regulatory affairs, commercial operations and others, using all current industry solutions such as Salesforce, Trackwise and inhouse developments.

Your Benefits

  • Successful projects thanks to PMI‐certified project managers who are experienced in life sciences
  • Increased quality and efficiency through intelligent requirements management with customers and users
  • Faster time to market as a result of agile processes and well‐coordinated PM(O) teams
  • Quicker acceptance and adaptation by business users thanks to experienced change guides and hybrid project managers

Against the background of scarce resources, we provide our customers with tangible solutions and clear processes for custom-fit portfolio management. The effect: higher value added with consistent means.

Program & Project Management

Get the mills grinding faster! Our experienced PMO teams will become the control center and early warning system for your project and facilitate your project's day-to-day business.

Roll Out Coordination & Support

Project Quality Management

Digital, mobile, available immediately – the requirements of business customers for their IT in the industry 4.0 era are tremendous. We help you meet these challenges: through an agile IT strategy, scalable processes and strong reporting.

Your benefits

  • Business IT as a valued partner of departments with harmonized goals and coordinated road maps
  • Scalable and viable processes through a best practices enterprise architecture framework
  • Improved perception of the value contribution of IT through reports using business‐related KPIs

IT Strategy & Governance

IT Performance Measurement

IT Quality Management

IT Architecture

A clean and efficient service management is indispensable to those who want to truly take advantage of current operating models, such as out‐tasking and cloud services. Because the foundation is laid via the processes!

With experience from over 100 successful projects within the field of life sciences, we resolve weaknesses in processes, organization and compliance of your service management in a targeted manner. In this way, we protect your financial capacities and secure your “return on investment.”

Your benefits:

  • Exploiting the potential of modern (cloud) service management without losing transparency and cost control
  • Higher quality and performance through proven increased process maturity
  • Benchmark and proof of performance of your IT

IT Service Management Strategy

IT Service Management Optimization

Evaluation & Implementation of ITSM Software

ITIL Trainings

In today’s continuously changing, often disruptive business environment, it is more important than ever to align applications to business processes and corporate strategy. With more than 10 years of experience in application portfolio management, we establish complete visibility in your application landscape to manage costs, ensure alignment, and easily adapt to change.

Your benefits

  • Reduce operational costs and complexity by eliminating application duplicates
  • Scalable and sustainable application landscape by evaluating the most efficient delivery methods and contracts for your portfolio
  • Guaranteed business suitability thanks to certified IT requirements engineers with life sciences background
  • Discover process optimizations throughout the application landscape with minor manual interactions through automated process mining.

Clouds, mergers and the trends towards greater standardization have brought near‐daily software rollouts to many companies. We make sure that these rollouts are carried out efficiently and on the basis of best‐practice testing methods across all stages: from test management to execution and documentation. You save time and money – before deployment and afterwards.

Your benefits

  • Testing as a Service: reliable, well‐documented results at predictable costs
  • Mitigate risks associated with new software through best‐practice test management and certified test resources
  • Integration of relevant GxP aspects into testing ensures compliance of solutions prior to roll‐out
  • Security of investment thanks to reusable, expandable test scenarios and scripts

Test Management

Testing

I was impressed by the work quality. Having less resources and a new team of developers, your consultant wisely prioritized the objectives and guided the team toward delivering quality results. Honestly, I learnt a lot of, her in many aspects.
Lead Scientist
Pharmaceutical Company
Overall good collaboration with the ARCONDIS team. Very good understanding of customers and projects, even with complicated and difficult topics. The ARCONDIS team represented true added value for the project!
IT Program Manager
Global Swiss transportation and logistics service provider
Very reliable and expertise in various industries and technologies. Can cope with complexity.
Business Solution Manager
Medical Device Company
They think outside the box! High level of enthusiasm, timely delivery and good communication in meetings.
Team Lead MDM Business Processes
Medical Device Company
Stefan has been an excellent project manager. I liked the way he identified one of the more challenging characters and then found a way to work well together. A very well run project that I enjoyed participating in.
Global R&D Portfolio Manager
Agriculture Company
​Lars is a motivated, skilled, organized, goal oriented, driven, pro-active and friendly person to work with. His engagement in this project was crucial for the achieved success.
Head E-Learning
Medical Device Company
Daniela quickly familiarized me with the complex certification topic in a determined and tireless manner. She represents the issues of the QP organization excellently in the Annex 16 program!
QA Release Manager
Pharmaceutical Company
The consultants are very professional. They take their roles and responsibilities very seriously. Normally I don't give any perfect scores as a matter of principle, but Christian gets a "10" from me. Excellent work!
Solution Manager
Global Swiss medical device manufacturer
ARCONDIS provided us with an experienced project manager who was able to quickly and efficiently replace the previous project manager. He also successfully completed two, not necessarily simple IDMP experiments.
Business Solution Manager
Pharmaceutical Company
Specialized professional competence in the area of software as a medical device was very helpful for our project. We would be very happy to work with ARCONDIS again in case we require consultancy.
Quality Manager
Medical Device Company
When I need some support, I know that I can rely on Özlem. She takes the time and always comes with pragmatic solutions should there be any issues. It is a real pleasure for me to work with her, she is an enrichment for us!
Regulatory Specialist
Agriculture Company
I am very happy with Boris' work and work ethics. There is not a single thing that I can think of that would be negative about his work.
Project & Development Systems
Medical Technology Company
I am extremely satisfied with the performance of the ARCONDIS consultants. They are experts in maneuvering through our not-so-simple, political environment.
Solution Manager
Global Swiss medical device manufacturer
Marina continues to deliver high value and in ambigous areas! She has continued to move things to the next level and while it will be hard to the project team to loose her I am happy she will be joining another one of our projects.
Trial Master File Manager
Global Swiss pharmaceutical corporation
ARCONDIS has been a tremendous addition to our programme!
Site IT Head
Global Swiss pharmaceutical corporation
Boris has been a strong and very talented team member. His performance does continue to exceed my expectations. His ability to remain level headed and artfully navigate a highly politically charged project has been outstanding.
Domain Head R&D IT
Medical Device Company
Very good planning and budget overview, very independent work, appears confident to internal customers, great negotiating skills and were able to familiarize themselves very quickly.
Information Manager
Pharmaceutical Company
The performance of ARCONDIS has been outstanding, going above and beyond my understanding of the expected tasks in several instances.
Development Excellence Leader
Pharmaceutical Company
I am very pleased with the overall quality of the personal that has been seconded to us from ARCONDIS. High quality, well qualified, reliable and professional when dealing with customers.
Domain Head R&D IT
Agriculture Company
High level of self-management and the "engine" of our projects!
Head of Quality Assurance
Chemical Company
My very limited knowledge was expanded by the competent work and collaboration with ARCONDIS. The proactive nature, targeted questioning and specific suggestions proved to be of great value to me.
Project Manager IT Quality Management Framework
Pharmaceutical Company
I would absolutely recommend both Mark and ARCONDIS. Mark’s thought-leadership has been invaluable, not just to his own project but to helping improve the program.
Program Manager for Global User Experience Program
Global pharmaceutical corporation
Benedikt is a professional who always put the client first. Having worked with Benedikt, I would highly recommend him.
Head of Digital Projects
Global pharmaceutical corporation
Christian is a very senior project manager who covers all areas of management and leadership within project and program level, for any change management initiative on any level. He can be recommended for any type of engagement of similar or even bigger scope on any level within IT, but even outside IT in general management
Global Head End User Experience
International Pharmaceutical Company
I appreciate the targeted, flexible collaboration with ARCONDIS. Immediate needs are responded to proficiently within 24 hours, and I feel proactively managed – a clear edge over the competition!
Head of Global ITO
Global Swiss biotechnology corporation
ARCONDIS is my prefererred supplier which I will approach whenever possible/needed. Also, I will recommend ARCONDIS at any time.
Head of Medical and Scientifc Systems
Global Swiss medical device manufacturer
I am really satisfied with the people at ARCONDIS and their performance!
Business Solution Manager
Global Swiss pharmaceutical corporation
I'm recommending ARCONDIS regularly to colleagues. I especially appreciate Hanno's creativity and he's very structured. His "10" should be an 11!
Digital Marketing Project Manager
Global Swiss pharmaceutical corporation
In this way, I’d once again like to express my complete satisfaction with collaboration with ARCONDIS. It was a real pleasure working with you!
Principal Leader
Global Swiss pharmaceutical corporation
The employees of ARCONDIS are reliable, straightforward and do a good job.
Team Lead Quality Control
Medical Device Company

We realize solutions. We ensure benefits that can be experienced with our sophisticated concepts and intelligent implementation. We have proven this time and time again in the past - for example with the following projects from your sector: