EXCO - Where Regulatory Compliance Meets Engineering
We advise you on all aspects of applicable standards, General Safety and Performance Requirements (GSPR), and other regulatory requirements for market access. Our experts conduct comprehensive gap assessments and help you prepare effectively for audits, ensuring your organization remains inspection-ready and compliant. By combining Regulatory Affairs, Quality Management, and Engineering expertise, we translate complex regulations into practical development, evidence-generation, and documentation strategies that support efficient and compliant product development.
With our scalable Medical Device Services, you can focus on innovation while we support regulatory compliance and adherence to relevant industry standards throughout the entire development and market approval process.
EXCO Services
Medical Device Services
Regulatory Strategy & Classification - MDR/IVDR
The journey to successful market access for a Medical Device or In Vitro Diagnostic (IVD) requires navigating complex regulatory requirements. EXCO supports you throughout the conformity assessment process, from device classification and regulatory strategy to the preparation of your EU Declaration of Conformity and successful CE marking.
Our services:
- Medical Device and IVD qualification and classification
- Development of a tailored regulatory roadmap
- Definition of an appropriate standards and compliance strategy
- Selection of the most suitable MDR and IVDR conformity assessment pathway
- Regulatory assessments and expert consulting
- Coordination of testing laboratories and regulatory stakeholders
- Support with market access planning for your target markets
Regulatory Compliance & Change Management - MDR/IVDR
MDR and IVDR requirements continue to evolve. EXCO supports you in identifying relevant regulatory changes at an early stage and assessing their impact on your products and processes.
Our services - Change Management:
- Support for MDR/IVDR transitions and implementation of new regulatory requirements
- Updates to Technical Documentation
- Support with product changes, certificate management, and communication with Notified Bodies
- Regulatory impact assessments for product and process changes
Our services - Regulatory Compliance:
- Classification and conformity assessment of Medical Devices and In Vitro Diagnostics (IVDs)
- Implementation of UDI and labeling requirements
- Support with market surveillance, vigilance, and EUDAMED requirements
- Standards research and analysis
- Consulting and support for the Person Responsible for Regulatory Compliance (PRRC) in accordance with MDR and IVDR
- Support with post-market surveillance and post-market compliance requirements
This helps you stay up to date with current regulatory requirements and provides the basis for maintaining MDR/IVDR compliance and certification.
Quality & Risk Management
As an ISO-certified company, we support you in continuously developing your Quality Management System (QMS) in accordance with ISO 9001 and ISO 13485, identifying regulatory gaps at an early stage, and maintaining long-term compliance. From gap analyses and reviews of quality-related documentation to audit preparation and the optimization and digitalization of quality processes, we provide targeted support where it is needed most.
Quality Management Services:
- QMS Consulting to ISO 9001 and ISO 13485
- Implementation, Optimization, and Continuous Development of QMS to ISO 9001 and ISO 13485
- Quality management training and customized workshops
- QMS Digitalization
- Gap analyses and QMS assessments
- Creation, revision, and review of quality-related documentation
- Preparation of GSPR evidence and traceability matrices
- Inspection readiness through mock audits, internal audits, and preparation for regulatory inspections
- Support for certification audits, regulatory inspections, and notified body audits
- CAPA management and post-inspection support
- Continuous improvement of processes and systems
Risk Management Services:
- ISO 14971 risk management
- Facilitation of risk analyses
- Consulting and optimization of risk assessments
- Optimization of standard operating procedures
Verification & Validation
To bring a medical device to market safely and in compliance with applicable regulations, all requirements related to functionality, performance, and safety must be demonstrably fulfilled.
Verification and validation activities provide the evidence required for approvals, audits, and regulatory inspections while helping to minimize risks throughout the development process. EXCO supports you from test strategy and execution through to complete documentation.
Our services:
- Mechanical testing, environmental testing, and EMC testing
- Design verification and product testing
- Manual and automated software testing, including integration, system, and ad hoc testing
- Development of test frameworks and test automation solutions
- Code reviews
- Qualification, process validation, and method validation
- Test laboratory coordination
- Preparation of quality-relevant and technical documentation to MDR and IVDR
Learn more: Medical Device Development Services
Technical Documentation - MDR/IVDR
Our experts support you in bringing your medical device to market in compliance with regulatory requirements and ensure that your technical documentation meets current regulations. Through our Audit & Inspection Readiness services, we evaluate how well your documentation is prepared for audits, Notified Body assessments, and MDR/IVDR conformity assessment procedures.
Our services:
- Consulting, preparation, review, and optimization of technical documentation to MDR and IVDR
- Structured gap analysis of technical documentation for completeness, plausibility, and regulatory compliance
- GSPR review
- Traceability assessment between requirements, evidence, and documentation
- Early identification of regulatory risks and compliance gaps
- Preparation for audits, Notified Body assessments, and approval procedures
CE Marking & EU Conformity Assessment
Have you developed a product and want to bring it successfully to market? Then CE marking is an important step towards legally compliant market placement.
We support you throughout the entire EU conformity assessment procedure, from requirements analysis, quality management systems (QMS), processes, and technical documentation to audits, inspections, and assessments by Notified Bodies or competent authorities, through to the preparation of the EU Declaration of Conformity and CE marking.
Our services:
- Analysis of applicable directives, regulations, and standards, such as the Machinery Regulation (EU) 2023/1230 and the Low Voltage Directive 2014/35/EU
- Standards and regulatory research as well as compliance assessment
- Execution and support of conformity assessment procedures
- Preparation, review, and optimization of technical documentation and technical files
- Risk assessments and demonstration of product safety in accordance with relevant standards, including DIN EN ISO 12100, DIN EN ISO 13849, and DIN EN 60204-1
- Support with test strategy, verification planning, and coordination of external testing
- Support in cooperation with testing laboratories
- Preparation of the EU Declaration of Conformity and support with CE marking
- Consulting and training on product compliance and EU conformity
With EXCO, you receive all services related to CE marking, technical documentation, and product compliance from a single source. This enables you to bring your products to the European market efficiently, safely, and in full compliance with applicable regulations.
Post-Market Surveillance & Lifecycle Compliance
Even after market approval, EXCO supports you in maintaining regulatory compliance throughout the entire product lifecycle. We assist with the planning and implementation of post-market activities, monitor regulatory changes, and support the assessment of product modifications to ensure the ongoing compliance of your medical device.
Our services:
- Support for post-market surveillance (PMS) and post-market performance follow-up (PMPF)
- Support for post-market clinical follow-up (PMCF)
- Vigilance management and support with reporting obligations
- Assessment of changes to standards and regulatory updates
- Assessment and documentation of product changes
- Support in maintaining MDR and IVDR compliance throughout the entire product lifecycle
EXCO's Quality Standard
Certified by TÜV SÜD to EN ISO 13485:2016 and DIN EN ISO 9001:2015
EN ISO 13485:2016 - The Provision of Design and Development Services for Components, Semi-Finished Products and Manufacturing Processes for Medical Devices and In Vitro Diagnostics. The Provision of Development Services and of Testing and Production Equipment for the Manufacturing of Medical Devices and In Vitro Diagnostics, including Robot-Based Physical Testing for Use within Product Development, Verification or Validation Activities. The Provision of Regulatory Affairs Services for Medical Devices and In Vitro Diagnostics. The Provision of Qualification and Validation Services for the Manufacturing of Medical Devices and In Vitro Diagnostics.
DIN EN ISO 9001:2015 - Design and development of components, semi-finished products, manufacturing processes, software as well as production of test and production equipment as well as provision of services in laboratory analysis
Why EXCO for Medical Device Conformity Assessment and Market Access?
Certified to ISO 13485 and ISO 9001, we apply the high quality standards required for the successful development and approval of medical devices.
With EXCO, you benefit from a comprehensive range of services covering the entire product lifecycle. From regulatory affairs and technical documentation to quality and supplier management, as well as UDI and EUDAMED, you receive all relevant services from a single source. This reduces interfaces, saves time, and ensures that you always have a central point of contact by your side.
Explore our full service portfolio: EXCO Services
We support you in implementing current MDR and IVDR requirements, assess regulatory changes, and help ensure that your products and processes remain compliant throughout their lifecycle.
EXCO supports you not only with individual projects but also as a long-term partner, helping you continuously develop your products, processes, and regulatory strategies.
Our goal is to make regulatory approval processes as efficient as possible, identify regulatory risks at an early stage, and support you in bringing your products to market safely and successfully.
Every medical device has unique requirements. That is why we provide solutions tailored to your products, processes, and regulatory challenges.
EXCO Sevices
EXplore our EXCO Services
As a full-service provider, we support SMEs and large corporations with high-quality technical solutions in software engineering, systems development, automation, and quality assurance for highly regulated markets. Our customers include companies in the medical technology, pharmaceutical technology, biotechnology, chemical, and food technology sectors, as well as other regulated industries.
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