MEDICAL SERVICES, CLINICS & LABS

The market for medical services, clinics and labs is developing rapidly. Like the medical and pharmaceutical sector as a whole, this area is characterized by increasing regulatory requirements, technological advances and the growing demand for innovative healthcare solutions.

Driven by demographic change, the increase in chronic diseases and technological innovations such as molecular diagnostics and personalized medicine, the market environment is continuously changing. At the same time, point-of-care and self-tests are gaining in importance, which could have long-term effects on traditional laboratory services. The integration of automation and AI into laboratory processes also promises increased efficiency and more precise diagnoses. Compliance with international regulations such as MDR or FDA requirements, the integration of new technologies and ensuring the highest quality standards are crucial success factors. At the same time, these developments offer enormous opportunities: digital health solutions, networked medical devices and optimized laboratory processes can improve patient care and open up new markets.

EDAG Group: Development expertise for the highest standards

The EDAG Group is positioning itself as a strong development service provider in this dynamic environment. With our comprehensive expertise, we support you throughout the entire development process – from product development to prototype construction and testing, to regulatory advice and documentation. We optimize medical devices, develop digital health solutions, and ensure that your products meet the highest quality and safety standards.

Our in-depth knowledge of medical technology and our experience with regulatory requirements enable us to ensure a fast, compliant market launch and the continuous optimization of your products and services. Benefit from our innovative strength to secure a competitive advantage and actively shape the future of healthcare.ugestalten.  

get in Touch

• Requirement

  A provider of diagnostic systems needs support in obtaining approval for a portable medical diagnostic system – both according to MDR (EU) and FDA (USA).

  • Preparation of technical documentation (including product description, risk management, clinical evaluation).
  • Conducting the necessary inspections and tests (e.g. EMC, biocompatibility, software validation).
  • Approval process for the EU (CE marking) and the USA (FDA approval).
• Solutions

  The EDAG Group offers comprehensive support with regulatory documentation and product approval:

  • MDR (EU): classification, conformity assessment, creation of technical documentation, performance of necessary tests and support with CE marking.
  • FDA (USA): support with 510(k) approval, creation of FDA documentation and preparation for FDA inspections.
  • Interdisciplinary expertise: advice on compliance with quality management systems (QMS), design controls and regulatory requirements.
• Your benefits
  • Fast market access: An expedited approval process shortens time to market.
  • Minimization of risks: Ensuring full regulatory compliance reduces legal and safety risks.
  • Secure compliance and high quality: MDR- and FDA-compliant approval increases the trust of customers and authorities.
  • Cost and resource savings: The EDAG Group takes over documentation and processes, reducing administrative work and avoiding delays.

• Requirement

  Comprehensive training is required to ensure that medical personnel (doctors, nurses) can use new medical devices efficiently and safely. The challenge lies in the complexity of the devices and the need to learn how to use them quickly and without putting real patients at risk:

  • Minimize training effort: Traditional training is time-consuming and costly.
  • Avoid safety risks: Medical personnel must be able to train safely and without risk to patients.
  • Ensure scalability: Training should be available to many employees at the same time, regardless of location.
• Solutions

  With “Smart People”, the EDAG Group offers a VR-/AR-supported training solution for medical personnel:

  • VR training: virtual reality enables risk-free simulations in which staff can operate the devices in full without physically interacting with the real device.
  • AR applications: Augmented Reality complements the training with interactive overlays (e.g. instructions, warnings, diagnostic tips) that can be seen directly on the real device.
  • Interactive scenarios: Tailor-made training modules for emergency situations, maintenance and complex applications guide staff step by step through all relevant processes.
• Your benefits
  • Efficient training: shorter training times with reduced resource requirements thanks to practical simulations. By using VR/AR technology to train medical personnel, the EDAG Group offers an efficient solution that trains medical personnel to use new medical equipment faster and more effectively.
  • Error reduction: risk-free training makes it possible to identify and avoid errors before the device is used in real operation. This simultaneously increases patient safety. Virtual and augmented reality offers a practical experience that complements and often surpasses traditional training methods.
  • Highly scalable and flexible: Cross-site and device-independent training for large groups of employees enables medical staff to be qualified quickly and uniformly.
  • Cost savings: Digital VR/AR programs significantly reduce training costs by reducing the need for classroom training and physical training equipment.
  • Secure compliance and quality: Training is adapted to regulatory requirements (e.g. MDR) and ensures certified staff training.