Medical devices consulting
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Stefan Eckert
Stefan Eckert

IT Management for medical device companies in the medium‐sized business sector

The future belongs to your IT management.

Despite increasing requirements of agility and reliability, cost pressure on IT departments in medium‐sized businesses is particularly high. In addition, it is expected of IT managers and CIOs that they make technologically and economically sustainable decisions.

Big Data, Cloud Computing, Digital Transformation and Mobile Applications – for over 18 years, ARCONDIS has been advising medium‐sized medical device companies (SMEs) and has been helping them establish a sustainable IT in the midst of a modern jungle of innovations. An IT management that develops from the cost center to the service provider to the modern business partner.

More than 125 successfully implemented Projects speak for the success of this strategy.

 

From consulting to implementation – everything from a single source.

Due to our acquired experience, we are not only able to provide strategic consultation, but our interdisciplinary certified Teams also support efficient implementation. In this way, they also ensure a strong positioning of your IT and a higher value proposition.

For this purpose, ARCONDIS first identifies your potential for optimization and streamlines existing processes, thereby creating new leeway for your IT management for the targeted use of modern types of business, such as out‐tasking or cloud services, for example.

In addition: The digitalization of business divisions requires new dimensions of networking, availability and – especially in the medical device environment – quality assurance.

 

ARCONDIS is also expertly by your side here.

Thanks to our highly efficient information landscaping methodology, we create transparency across the processes, structure and technology application of your IT: IT receives a map, so to speak, and becomes navigable.

This opens up options for action that allow you profitable activities as part of industry 4.0.

Conclusion: ARCONDIS creates a modern strategic vision for your IT management that meets your needs precisely. One call to one of our Locations and you will know more!

Our Services

In more than 150 qualification projects, we have been able to prove: We create intelligent solutions, which, in addition to fulfilling official requirements, increase the value contribution to the infrastructure through stable processes and reliable services in a cost‐effective way!

Your benefits

  • High audit security with overhead‐optimized implementation through our experienced qualification experts
  • Avoiding redundant work by applying onboarding with the help of an integrated qualification strategy
  • Cost‐reduced operation while simultaneously guaranteeing compliance through controlled IT processes according to best practices

With an effective IT QMS you can accomplish two goals at the same time: You can enhance the contribution made by IT through stable and reliable services while demonstrably meeting the requirements of regulated IT. A QMS is effective – both internally and externally. We’ll show you how!

Your benefits

  • Inspection readiness while simultaneously increasing your performance by using lean, controlled IT processes according to best practices
  • Proof and monitoring of performance and conformity with regulations related to IT in the company and to external authorities
  • Faster and higher acceptance of the QMS among employees due to proactive organizational change management according to Prosci and PCI

IT Quality Management Frameworks

IT QMS Compliance Checks & Optimization

QMS Tool Evaluation & Implementation

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 Master Data 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 Medical Devices

Validated Clouds

Validation of Life Sciences specific Business Solutions

Validation of Enterprise Solutions (ERP, Excel…)

CSV Trainings

Whether it be enterprise software or a specialized business application, an in‐house development or an industry solution: in more than 150 projects, we have significantly increased the business fitness, the degree of integration and the acceptance of solutions among stakeholders and users through intelligent business analysis and sophisticated requirements management.

How we can help you:

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

Leading edge technology, cost minimization and zero downtimes: the demands on modern IT are substantial. By using effective project management, you gain agility and the ability to act in your organization, and at the same time, guarantee the stability and reliability of your services.

We make your projects successful with our expertise and passion: from the growing IT infrastructure to the perfectly tailored business solution in research, development, regulatory affairs and commercial operations.

Your benefits

  • Successful projects from PMI‐certified project managers who are experienced in the life science sector
  • Quick integration of new technologies, such as mobile apps and hybrid clouds
  • An increase in quality and efficiency through intelligent requirements management with customers and users
  • Faster time to market through agile methodology and rehearsed PM(O) teams

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.

Project Management Frameworks

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.

Project Quality Management

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 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

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

Service Outtasking, Cloud Computing und Big Data — current compliance requirements as well as efficiently organized business processes require sophisticated and effective master data management (MDM) of processes and systems.

We realize the value of strategic data management for our customers, from ideal MDM governance and organization to seamless processes to their optimal technological implementation.

Your benefits

  • In‐depth pharmaceutical business process knowledge combined with certified MDM expertise
  • Targeted identification and rectification of weaknesses through efficient MDM maturity assessment
  • Faster acceptance and adaptation of MDM initiatives by IT and specialized departments due to experienced change guides

MDM Strategy & Concepts (incl. Maturity Assessment)

MDM Implementation & Optimization

MDM Tool Evaluation & Implementation

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

In the face of increasing attacks and advancing digitalization, companies must prioritize the protection and integrity of their operational data. Take advantage of our extensive experience and regulatory industry expertise. We take care of everything you need, from the conceptualization of ISO‐compliant information security management systems to their operative implementation and auditing.

Your benefits

  • High audit security through our certified security experts
  • Proactive risk mitigation through audit pre‐checks and closing gaps beforehand
  • Reduced operational risk while simultaneously guaranteeing compliance through controlled IT processes according to best practices
  • Improved trust in data and business decisions derived therefrom
​Very happy - trustful relationship and professional cooperation. Sometimes, you should slow down a little bit and not kill yourself.
Business Solution Manager
Medical Device Company
Always available when needed and always going the extra mile to ensure success of the team.
Project Manager
Pharmaceutical Company
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
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
As always, a very dedicated support throughout the year. Boris and Janik were instrumental in the development stream and thanks to their dedication and passion, we achieved all of our goals.
Global Swiss medical device manufacturer
Principal Project Manager
The employees of ARCONDIS are reliable, straightforward and do a good job.
Team Lead Quality Control
Medical Device 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
Christian gets 11 of 10 points. I just can dump work on him and it is getting done! 100% reliable, very good in service management, project management even better.
Business Solution Manager
Pharmaceutical Company
Thomas has done a fantastic job. He has significant expertise around mobile apps and also has proven very capable delivering results as an IT Project Manager. We would be delighted to work with ARCONDIS and Thomas again.
Business Information Manager
Pharmaceutical 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
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
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
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
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
I'm very happy with the people and the quality ARCONDIS is providing!
Team Lead Global Product Strategy Informatics
Global Swiss pharmaceutical corporation
Mark is a real good project manager and is extremely capable. If you let Mark fill in the space, he is doing it, never hesitating to drive and step to the plate. Extremely valuable. Mark is going the extra mile with one idea in mind: make sure the project progresses!
Global Head of Digital Services Delivery
Pharmaceutical Company
Joachim is a critical team member. He exceeded impossible expectations.
International Patient Innovation Director
Global Swiss 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
Arcondis values quality and delivers quality. They make sure of this by carrying out regular customer contact, follow-ups and regular status comparisons.
Head Workplace Productivity
Chemical Company
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
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
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
I would recommend the service from ARCONDIS because it is straight forward and performed with high quality. Also I do appreciate the open and honest environment working together with ARCONDIS.
Global Project Manager
Medical Device Company
Very reliable and expertise in various industries and technologies. Can cope with complexity.
Business Solution Manager
Medical Device 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
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
​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
ARCONDIS has been a tremendous addition to our programme!
Site IT Head
Global Swiss pharmaceutical corporation

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: