Industries.
Medical technology consulting.
Advice on MDR, ISO 13485 and regulatory market access - safely through all phases of the product life cycle.
With the introduction of the MDR, supplementary regulations such as the MPDG and global standards such as ISO 13485 or FDA 21 CFR 820, the requirements for traceability, technical documentation and auditability are increasing significantly. At the same time, the challenges are growing due to cybersecurity risks, UDI obligations and the integration of digital systems such as ERP, LIMS and CSV solutions. Companies must not only develop in compliance, but also establish robust supply chains, validated IT processes and continuous market surveillance structures.
With comprehensive medical technology expertise, detailed regulatory knowledge and operational implementation expertise, we support you from product development and market access to sustainable compliance in the market. We optimize your quality management systems, stabilize your supply chains, support you in the implementation of post-market surveillance and ensure your audit readiness - forward-looking, practical and tailored to your corporate goals.
Our consulting fields - regulatory, operational and technologically networked.
Regulatory & Compliance.
- Regulatory Affairs - Strategic advice and coordination of approval processes
- MDR readiness - planning and implementation of MDR requirements in your company
- FDA approval of medical devices - PMA, 510(k) and pre-submission strategies
- CE approval & CE marking - Preparation of technical documentation in accordance with MDR
- Inspection readiness - systematic preparation for audits by authorities and notified bodies
- Technical writing - creation of regulatory compliant content (e.g. IFUs, labeling, CER)
- Risk management - implementation according to ISO 14971 with complete risk file
- Clinical compliance - ensuring the conformity of clinical activities according to MDR
- Change management compliance - compliant control of changes in the lifecycle
- Health Authority Interaction - Coordination of scientific advice and audits with authorities
- International market access - strategies for worldwide submissions and approvals
- ISO audits - support with preparation and implementation in accordance with ISO 13485 and 9001
- Mock audits - Simulated inspections to prepare for audits by authorities
- Labeling & IFU creation - testing, design and validation of MDR-compliant labels
- 21 CFR Part 11 and data integrity - implementation of US regulatory requirements for electronic data
- UDI Management & EUDAMED - Structured management of product identifications and EUDAMED data
Clinical & Medical Affairs.
- Clinical Affairs - Strategic study planning, endpoint definition and study architecture
- Clinical evaluation (MDR / MEDDEV) - creation and updating of regulatory compliant evaluations
- PMCF (Post-Market Clinical Follow-up) - Systematic collection of additional clinical data after market approval
- Clinical Project Management - coordination and monitoring of complex study projects
- CRO support - assistance with the selection and management of service providers
- Clinical monitoring - quality control in study centers and data flow
- Medical writing - preparation of protocols, IBs, CSRs etc.
- Post Market Surveillance - Long-term monitoring after market approval
- Signal Detection - data analysis for risk detection and early warning
- GCP compliance - ensuring adherence to clinical standards
- Medical Device Vigilance - Establishment and control of incident reporting processes
Quality Management & Operational Excellence.
- ISO 13485 QM systems - Development and maintenance of a standard-compliant quality management system
- State of the Art Assessments - Evaluation of current standards in the product context according to MDR
- Complaint management - MDR-compliant complaint handling with systematic evaluation
- CAPA management - identification, implementation and follow-up of corrective and preventive measures
- Deviation management - analysis and documentation of deviations in the process
- Process validation - proof of robust and reproducible manufacturing processes
- Continuous Improvement Programs - Sustainable optimization initiatives in operations
- Lean Lab - Optimization of laboratory processes through structured workflows
- Lean Six Sigma - Data-based process improvement and error reduction
- ISO 9001 Audit - Preparation, implementation and follow-up of audits according to ISO 9001
Research & Development and Engineering.
- Design Controls - Structured development according to regulatory requirements
- Usability engineering - user-centered design and risk minimization
- Verification & Validation - testing product specifications and processes
- Biocompatibility studies - Evaluation of material compatibility according to ISO 10993
- Feasibility studies - analysis of the feasibility of technical concepts
- Prototyping - development and testing of functional samples
Manufacturing and Supply Chain Management.
- Good Manufacturing Practice - Implementing regulatory compliant production processes
- Production Transfer & Scale-Up - Efficient transition from development to series production
- Supplier Development & Qualification - Selection, evaluation and auditing of suppliers
- Good Distribution Practice (GDP) - Ensuring regulatory requirements in distribution
- Supply chain governance - structured management of responsibilities and processes
- Lean manufacturing - increasing efficiency through lean production processes
- Sustainable Manufacturing - Sustainable production taking regulatory aspects into account
- Energy & Resources Management - Conserving resources in regulated environments
- Dealing with supply bottlenecks - risk minimization and responsiveness in the supply chain
- Optimizing supply chain management - structuring and digitalizing SCM processes
- CapEx - support for investment projects in a regulatory context
- M&A & PMI - Advice on acquisitions and integration of medical technology organizations from a compliance perspective
Business Data Solutions & IT Services.
- Digitalization - Digital transformation of regulatory and operational processes
- Digital governance - management and control of digital systems in a regulated environment
- Computer System Validation - Validation of computerized systems according to GAMP 5
- Data Integrity Assurance - Ensuring electronic data is compliant with regulatory requirements
- ERP integration - integration of ERP systems into regulated processes
- IT process management - structuring and improving IT-supported processes
- Reporting & dashboards - setting up transparent reporting structures for audits and management
- Audits & QA of digital systems - Testing IT systems for GxP compliance
- Technology Excellence - Identification and introduction of innovative digital technologies
Take advantage of regulatory clarity and operational strength.
Successful consulting projects in medical technology consulting.
Project type: Hybrid Consulting.
Challenge.
A manufacturer of active medical devices was facing an MDR audit and had difficulties with complete technical documentation and post-market activities.
Measures.
Creation of an MDR-compliant technical file. Implementation of a PMS plan. Conducting an internal mock audit with subsequent implementation of corrective measures.
Results.
- Audit passed without major findings
- Technical documentation fully digitized
Success.
The company was classified as "exemplary MDR-ready" by the notified body.
Get to know our experts.
Get in touch with our medical technology experts.
Dr. Jennifer Neff
Dr. Julia Beck
Do you want to secure your medical
technical processes from a regulatory perspective and optimize them operationally?
FAQ - Frequently asked questions about medical technology consulting from Entourage.
We specialize in the life sciences sector - with a focus on medical technology, pharmaceuticals, biotechnology and IVD. Our consultants have many years of experience in the industry: they have previously worked as QA managers, regulatory leads or clinical affairs experts.
What makes us special:
- In-depth regulatory expertise with a focus on MDR, ISO 13485, UDI and vigilance
- Operational implementation experience directly from everyday medical technology
- Experience with Notified Bodies, FDA, Swissmedic and international markets
- Process-oriented consulting that integrates into your structures - strategically and operationally
Our services can be flexibly adapted to your project requirements:
All models are modular, scalable and geared towards life science requirements.
We advise:
Start-ups with a focus on MDR implementation and 13485 certification
Medium-sized MedTech companies with growing audit and documentation requirements
International manufacturers with complex product portfolios and market access targets
Yes - we offer MDR, FDA, Swissmedic and BfArM readiness programs, inclusive:
- Mock audits
- CAPA strategy development
- Documentation and data integrity check
- Support for dialog with authorities
- Support during the on-site inspection
- Kick-off & target definition
- Gap analysis or process mapping
- Joint project planning with clear role allocation
- Implementation & review cycles
- Handover, reporting & lessons learned
Project types range from 2-week sprints to GMP, CSV or QMS implementations lasting several months.
We work transparently and precisely:
- Fixed daily rates or project-related offers
- No hidden additional costs
- Option of interim solutions for longer resource requirements
Yes - online or on site. Examples:
- MDR basic training
- Technical documentation & Annex I
- Audit behavior & CAPA culture
- QMS training for new locations
- CSV & Data Integrity according to GAMP 5
Yes - in the event of inspection preparation, acute quality problems or breakdowns, we can provide support within 48 hours - nationally and internationally.
