Medical Devices Consulting
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Rob Stijlen
Rob Stijlen
Home | Industries | Medical Devices | Global corporations | Business Applications

Business Applications in global medical device corporations

Our Expertise for Your Success.

3D printing, wearables and mobile health apps – innovation of business applications is a competitive advantage in more than just the retail business. It is also advantageous for global medical device manufacturers who are inundated with regulatory requirements.

It is reassuring to know: ARCONDIS and its interdisciplinary Consulting Teams have the expertise to create flawless, agile, GxP-compliant technological solutions by using state-of-the-art technologies, even for the most complex processes in the medtech industry.

 

Increase dynamics & efficiency of your Business Applications

This solution will completely meet the dynamism of your organization and your global footprint in every respect.

This is because, for example, we integrate the regulatory requirements in the project planning already at an early stage, thereby ensuring the GxP Compliance of your solution right from the start.

From engineering to technical documentation to commercial operations: More than 300 successful Projects in the business applications field of the medical device industry guarantee that we also offer you a real added value.

Three of the five largest medical device companies are already taking advantage of our consulting expertise. They have been relying on our service expertise for many years.

Would you like detailed consultation on the topic of business applications in global medical device companies? Then 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 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

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 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 pharmaceutcal corporation
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
Jan is unquestionably one of our most valued team members. Extremely competent, always polite and professional while remaining personable and eminently likable. Has a great no-nonsense approach: meetings with Jan are never unnecessary and never over-run. If we could clone Jan, we would!
Mobile and Wearable Sensor Lead
Global Swiss pharmaceutical corporation
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
The best Business Analyst with whom I’ve ever had the privilege to work.
Head of Mobile Services
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
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 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
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
Karin has done a great job of making sure that the plan is complete and staying on top of me to ensure that tasks are complete. Her character and personality, as well as her professionalism have been a credit to this project and are one of the key factors in how well it is running.
Technology Evaluation Lead
Agriculture Company
Incomparable response times and commitment! Last-minute requests are delivered quickly, with good quality. The "problem" is examined from different angles, opening up new perspectives. The colleagues at ARCONDIS are ready to support customers in all their concerns and go the extra mile.
Global Business Services
Global Swiss speciality chemicals corporation
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
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
Joachim is a critical team member. He exceeded impossible expectations.
International Patient Innovation Director
Global Swiss pharmaceutical corporation
Our ARCONDIS consultant constantly delivers timely and high quality output. She demonstrates very good communication with the scientists as well as with the informatics colleagues and is fully recognized in the role.
Leader Discovery Workflow
Pharmaceutical Company
I am really satisfied with the people at ARCONDIS and their performance!
Business Solution Manager
Global Swiss pharmaceutical corporation
ARCONDIS is the first place I go for consultation – they really stand out from other consulting companies: great people, unmatchable response times and a straightforward approach, no matter the request.
Head of Global ITO
Global Swiss biotechnology 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
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
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
Katharina is a very focused, professional, competent, dedicated and committed PM. She is also very nice and uncomplicated to work with, she manages herself extremely well. I would with no doubt recommend her to colleagues.
Business Solution 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
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
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
I'm very happy with the people and the quality ARCONDIS is providing!
Team Lead Global Product Strategy Informatics
Global Swiss pharmaceutical corporation
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
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 was impressed with the services that ARCONDIS have provided. It takes strength of character to handle constant changes and Jan has demonstrated he has the experience and also the professionalism to still thrive under pressure. He is fully integrated into the team and I look forward to continuing the engagement with ARCONDIS.
Data Governance
Global Swiss pharmaceutical corporation
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

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: