Medical devices consulting
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Volker Roeder
Volker Roeder

Quality and Compliance for medical device companies in the medium-sized business sector

We close gaps. And streamline processes.

The legal compliance regulations now constitute requirements that are more tailored to resource-rich global corporations than to medium-sized companies (SMEs).

The legal strengthening of patient rights, for example, means that you – in order to effectively handle complaints – must always pay careful attention to the informative value and unambiguity of your quality records.

Here, it is more than reassuring that the experienced compliance teams of ARCONDIS effectively close existing gaps to the ISO 13485.

But it is more than just the quality of the manufacturing process that determines Compliance and success – at the top of the FDA warning letter is an inadequate complaint management.

Lean processes. Innovative products.

Thanks to our lean compliance approach and their 18 years of experience in implementing it, our interdisciplinary Team of experts adhere to lean quality processes above all else so that you can bring innovative as well as safe products onto the market as quickly as possible.

They do this throughout the entire life cycle: from the validation framework to the UDI implementation to the efficient CAPA management. In this way, they allow you to react quickly in the event of time-critical quality decisions and pending inspections as well as to conserve your resources in operative business. Our service offering starts exactly where your opportunities lie: in risk and cost-oriented production.

We have proven that this concept works in around 100 successful Projects. We look forward to hearing from you at one of our Locations!

Our Services

Managing projects competently and intelligently is our passion.
Our project leaders combine deep compliance expertise with high-class project and change management. This allows us to create intelligent success through processes and solutions that are quickly adapted by the organization and that efficiently guarantee the fulfillment of the legal framework requirements.

Your benefits:

  • Implementation of official requirements through the perfect mix of project management and compliance expertise, while adhering to deadlines and ensuring it will pass inspection
  • Increased quality and efficiency through holistic requirement management from covering legal provisions to business fit for the specialist departments
  • Higher acceptance of new processes and rules through proactive change management

Project Management Frameworks

Project Quality Management

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.

Our experienced consultants prepare you optimally for audits. In doing so, you receive all services from one source: from the initial analysis to planning and implementing measures to the support of the audit itself. We also advise you on the targeted follow-up work and rectification of possible findings. Use our excellent service as preparation for official inspections and third-party audits, including mock audits if desired!

Your benefits

  • Need-based collection of status quos and possible gaps through tailored audit checklists, each according to the regulatory scope
  • Lean processes by prioritizing measures according to criticalness and urgency
  • Efficient and fast: audit and CAPA management from one source
  • Pass audits with confidence and sustainably establish audit readiness

Audit Preparation Service

Mock Audits

Audit Response Actions

CAPA Management

Qualifying and validating devices, systems and processes is an obligatory task in pharmaceutical manufacturing. Above all, this task must be audit-secure and efficient. In the cooperation with our tried and proven partners, we offer this perfect mix: excellent conception, guidance and monitoring through our compliance project leader with reliable and sophisticated test implementation through our partners.

Your benefits

  • High audit security with cost-optimized implementation through our team’s optimal combination of expertise
  • Overhead-reduced, risk-based procedure, proven by hundreds of applications
  • Minimal management need on the client side due to our experienced project leaders and proactive status reporting
  • Quantifiable investment with guaranteed returns, both as regards quantity and quality

Process Validation

Equipment & Facility Qualification

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

Companies in the medical device industry have the double burden of auditing not only their own products, but also purchased services and suppliers. Our certified and experienced auditors relieve your internal teams and take over the overall auditing responsibility in a cost-effective manner, from planning to implementation to the audit report.

Your benefits

  • Professional planning and implementation of internal and external audits for supporting and relieving internal auditors
  • Neutral assessment through independent experts
  • Short-term availability of Lead & Co auditors
  • Certified auditors with many years of practical experience

Supplier Audits

Mock Audits

Internal Inspections

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

Quality Management in regulated industries is more than reaching GxP compliance. A sustainable Quality System (QS) is the basis of your business’s success. With an effective QS, you will increase the value contribution of the quality assurance through stable and reliable processes and fulfill regulatory requirements demonstrably in the process.

Your benefits

  • Market- and need-based QS tailored to your company with appropriately high internal and external acceptance
  • Fulfillment of applicable regulatory requirements while simultaneously avoiding over-interpretation
  • Securing your business success through targeted and cost-conscious quality management processes

Compliance Checks & Optimization of Quality Management Systems

Introduction & Optimization of Quality Processes

Benefit from tailor-made in-house training sessions based on your compliance framework. From awareness of compliance issues to process-specific expert training!

Enormous pricing pressure, increasing commodity prices and intensified regulatory requirements demand of medical device manufacturers that they make a new maturity class of processes with regard to efficiency, costs and compliance. We have been successfully supporting our medical technology customers in the optimization of their process landscape in the GxP environment and beyond for 15 years.

Your benefits

  • Ongoing and lean business process framework from governance to SOPs, certification-ready
  • Increasing agility and avoidance of faults through the transparency of the business and quality processes
  • Best practices process modeling and process documentation, independent of the software used (Adonis, ARIS, Visio and many more)

Business Process Management Frameworks

Business Process Analysis & Optimization

Process Modeling & Documentation

Quality Operation is the daily business part of the QMS. Our experienced staff supports tasks such as CAPA Management, Complaint Handling, Change Control or Document Control. Different operational models are possible, e.g. managed services which are adapted to your needs.

Your benefits

  • Lean compliance with overhead-optimized operations through our experienced experts
  • Compliance across the entire quality system life cycle by implementation of Best Practices
  • Eliminate backlogs in the operational quality business
  • Flexible resource allocation — master variability of workload
  • Benefit from a pool of qualified resources — the right skills for the right task

Current trends in the life science industry such as the individualization of the health care sector and increasing compliance requirements from authorities combined with a growing cost pressure demand a focus of quality and compliance processes to their bare essentials.

LEAN methods provide a proven way to get rid of wasteful processes and allow our customers to focus on improvements and innovation.

Your benefits

  • Streamlined and result-focused, yet highly compliant processes
  • Increased inspection readiness due to greater availability of resources and information
  • Time and resources to focus on innovation
  • “LEAN mindset” leads to higher employee satisfaction, more proactivity of your colleagues and better company or department performance

Service for regulated companies to review the quality agreements and related documents such as quality technical agreements, SLAs, other contractual agreements for GxP, ISO requirements, legal aspects and due diligence. Different operational models like managed services are possible.

Your benefits

  • Eliminate backlogs in the operational quality business
  • Flexible resource allocation — master workload peaks
  • Outsource operational work due to limited in-house resource
  • Benefit from a pool of qualified and experienced resources — the right skills for the right task

Agile organizational models and constantly rising regulatory demands are resulting in rapidly changing process and system landscapes.  Maintaining a GxP-compliant environment thus presents a challenge for the entire team. Our experienced trainers increase the productivity of your staff through customer-specific training with actual application cases from your daily practice.

Your benefits

  • Tailored training based on your compliance framework, from sensitizing your employees to process-specific expert training
  • Avoidance of over-fulfillment of regulatory requirements as a result of lacking evaluation skills
  • Reduced compliance costs through increased productivity
Work very flexibly and customer-oriented, even under big time constraints!
Head of Innovation in Global Manufacturing and Supply
Pharmaceutical Company
​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
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
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
High level of self-management and the "engine" of our projects!
Head of Quality Assurance
Chemical Company
ARCONDIS has been working with me in one of the key projects in digital marketing area. Very strong in structuring the activities & meetings, always following up and pushing others for best results, productive and quick in getting outcomes.
Digital IT Business Partner
Pharmaceutical 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 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
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
The employees of ARCONDIS are reliable, straightforward and do a good job.
Team Lead Quality Control
Medical Device 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
ARCONDIS has been a tremendous addition to our programme!
Site IT Head
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
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 experienced, knowledgeable senior consultants!
Lead Continuous Improvement
Food Company
Joachim is a critical team member. He exceeded impossible expectations.
International Patient Innovation Director
Global Swiss 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
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
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
They think outside the box! High level of enthusiasm, timely delivery and good communication in meetings.
Team Lead MDM Business Processes
Medical Device Company
Dealings with different groups were done really professionally to push forward to goals. Marina is easy to work with and enjoys being part of the team, positive feedback from all of team. To me she's a rising star.
Project Manager
Pharmaceutical 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
Always available when needed and always going the extra mile to ensure success of the team.
Project Manager
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
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
Very reliable and expertise in various industries and technologies. Can cope with complexity.
Business Solution Manager
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
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
​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

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: