Medical devices
Development - Verification - Product approval
EXCO supports you with a comprehensive range of services for developing and managing the quality of medical devices. From your initial idea to product approval, we are your partner throughout the entire product life cycle.
We also ensure that your hardware and software reliably meet the specified characteristics. Our thorough verification process ensures compliance with all regulatory requirements and demonstrates the safety, robustness and high usability of your systems.
Our services for medical devices
Development of medical devices
With our DIN EN ISO 13485 certification and many years of expertise, we are your strong partner for the development of innovative and safe medical devices.
Our services:
- Concept development and prototyping
- Software as a Medical Device (SaMD) in accordance with IEC 62304
- Design of electronic components and assemblies
- Development of embedded software, firmware and apps for medical devices
Hardware and software design verification
EXCO supports the safe and standard-compliant development of medical devices by conducting thorough testing of the hardware and software. By doing this, we guarantee compliance with all the necessary standards for medical technology products, such as IEC 60601, IEC 62304, DIN EN 55011, DIN EN 60068-X, 61000-X and 62366.
Our hardware testing services:
- Mechanical testing
- Environmental testing
- Electromagnetic compatibility (EMC) testing
- Preparation of technical documentation in accordance with applicable regulations (e.g. IVDR, MDR, etc.)
Our software testing services:
- Interface testing
- Ad hoc testing
- Development of test frameworks for test automation
- Creation of relevant quality documentation (traceability, STS, etc.) in industry-standard ALM systems
Regulatory advice & approval
EXCO advises you on all questions relating to applicable standards and approval requirements for your product. We carry out GAP analyses, prepare you specifically for audits and support you in risk management. Our team of experts at EXCO also takes care of all technical documentation in compliance with the applicable quality standards and guidelines for your industry.
With our scalable Medical Device services, we support manufacturers from the initial idea to approval.
Our range of services
- Consulting on EU directives, regulations and standards (MDR, IVDR, ISO 13485)
- Conducting GAP analyses and audits
- Risk management according to EN ISO 14971
- Preparation and support for EU conformity assessment procedures
- Workshops, training courses and practical support for regulatory processes
With our expertise in regulatory compliance, quality assurance and product development, we help you efficiently navigate complex approval processes and bring your products to market safely.
Product safety
We protect your systems, applications and data with a tailor-made mix of technical and organisational security measures. As specialists in the field of usability testing for medical devices, we also ensure that your medical devices meet the high regulatory requirements.
Our services:
- Researching the applicable standards for your product
- Usability testing in accordance with IEC 62366 and FDA requirements
- Ensuring implementation of regulatory requirements Regulatory compliance in accordance with MDR, IVDR, IEC 62304 and ISO 13485
- Support in conducting device safety tests (including mechanical tests, electrical tests, usability tests, climate tests, EMC tests in an accredited environment (EN ISO 17025)
- Risk management
- Evaluation of test results
- Document review
- Preparation of technical documentation such as test reports, technical reports, etc.
- Consulting services on device safety
