Industries.
IVD Consulting.
Advice on IVDR, ISO 13485 and international market access - safely through all phases of IVD development.
Since the introduction of the IVDR, the in-vitro diagnostics industry is facing a new regulatory reality - we support you in mastering the stricter requirements with confidence.
The EU IVDR regulation requires significantly more extensive technical documentation, more in-depth clinical evidence and complete proof throughout the entire product life cycle. At the same time, the requirements for post-market surveillance (PMS), vigilance systems and labeling processes are increasing considerably. Many companies have to adapt existing systems, develop new products in compliance with IVDR and at the same time overcome additional challenges such as UDI implementation, EUDAMED connection and software-supported diagnostic products. International market access - for example to the USA, Canada or the UK - also requires new strategies and comprehensive regulatory expertise.
With specific IVD industry experience, in-depth regulatory understanding and operational implementation expertise, we guide you through all phases of the IVDR requirements. We support you in the development and implementation of robust quality management systems, the validation of digital processes and the establishment of sustainable compliance structures - practice-oriented, efficient and tailored to your individual requirements.
Our consulting fields in IVD Consulting - regulatory, operational and digitally networked.
Our services cover all regulatory relevant areas of in-vitro diagnostics - from development and approval to market surveillance.
Regulatory & Compliance.
Approval according to IVDR - structured, strategic and audit-ready.
- Regulatory Affairs - Creation and maintenance of IVDR-compliant technical documentation
- IVDR readiness - gap analysis and implementation of all IVDR requirements
- CE approval & CE marking - support in the conformity assessment procedure for IVDs
- International market access - strategies for approval outside the EU (FDA, UK MHRA, etc.)
- UDI management & EUDAMED - Structured setup of product labeling and data maintenance
- Labeling & IFU creation - creation of MDR/IVDR-compliant labels and instructions
- Health Authority Interaction - Communication with Notified Bodies and Authorities
- Change management compliance - implementing regulatory changes in the product life cycle
- Inspection readiness - preparation for audits and notified body inspections
- Mock audits - simulations to test audit capability
Clinical & Medical Affairs.
Performance evaluation & monitoring - IVDR-compliant and risk-based.
- PMCF (Post-Market Clinical Follow-up) - Post-Market Performance Follow-up and trend analyses
- Medical Device Vigilance - Establishment of a structured incident reporting system
- Signal detection - early risk identification in the market
- Clinical Project Management - Coordination of clinical studies or performance evaluations
- Medical writing - preparation of regulatory documents (PER, PMPF, SSCP)
- Clinical Affairs - Strategic study planning, endpoint definition and study architecture
- Post Market Surveillance - implementation of the PMS plan and annual reports
- GCP compliance - ensuring regulatory standards in studies and follow-up
Quality Management & Operational Excellence.
Systematically anchoring IVDR compliance - sustainably, audit-proof and efficiently.
- ISO 13485 QM systems - Development and maintenance of a standard-compliant QMS
- CAPA management - systematic tracking of deviations and measures
- Complaint management - MDR/IVDR-compliant complaint handling
- State of the art assessments - technology assessments in the context of performance requirements
- Cleanroom qualification - control and documentation of hygiene-critical environments
- Process validation - Validation of production processes for IVDs
- Continuous Improvement Programs - Optimization of existing QMS elements and processes
- Lean Lab - increasing efficiency in development or production laboratories
Research & Development and Engineering.
From the idea to the test - regulatory support for development.
- Design Controls - Structured development of IVD-specific products
- Verification & Validation - proof of regulatory and technical requirements
- Biocompatibility studies - material tests for e.g. sampling systems
- Usability engineering - user-friendliness and risk minimization
- Feasibility studies - feasibility assessment and early regulatory evaluation
Manufacturing and Supply Chain Management.
Secure and optimize production and supply chains from a regulatory perspective.
- Good Manufacturing Practice - Introduction and maintenance of GxP-compliant production processes
- Supplier Development & Qualification - Selection and auditing of quality-critical suppliers
- Production Transfer & Scale-Up - Regulatory secured production transitions
- Supply chain governance - responsibilities and risk management in supply chains
- Good Distribution Practice (GDP) - Good Distribution Practice in IVD delivery
- Lean manufacturing - efficient and compliant production processes
Business Data Solutions & IT Services.
Validating digital systems - compliant and future-proof.
- Digitization - ransformation of processes in the context of quality and documentation
- Computer system validation - GAMP 5-compliant validation of software tools
- ERP integration - reliable connection of ERP and laboratory systems
- Data Integrity Assurance - Ensuring data consistency and audit tr
- IT Process Management - Efficient and traceable IT-supported processes
Do you want to bring your IVD products to market successfully and safely in accordance with IVDR?
Successful consulting projects at IVD Consulting.
Our case studies show how we have solved regulatory challenges in the IVD industry efficiently and securely.
IVDR readiness in less than 12 weeks
Labeling and UDI system set up for 300 product variants
Market access planned for Companion Diagnostic in the EU and USA
Project type: Hybrid Consulting.
Challenge.
An IVD manufacturer had to revise its entire technical file to be IVDR-compliant at short notice in order to pass an upcoming inspection by the notified body.Measures.
Conducting a gap analysis, creating the new PER, updating the labeling structure and simulated mock audit.Results.
- IVDR test passed without major findings
- Labeling and UDI data structure completely revised
Success.
The company received a positive assessment and was able to secure market access.Get to know our experts.
Get in touch with our in-vitro diagnostics experts.
Sven Hoffmann
Head of IVD
Stefan Geelhaar
Principal Consultant
Ready for IVDR-compliant processes and safe approval?
FAQ - Frequently asked questions about IVD consulting from Entourage.
We specialize in the life sciences sector - with a focus on IVD, medical technology, pharmaceuticals and biotechnology. Our consultants have many years of experience in industry and regulatory projects: many have previously worked as QA leads, regulatory managers or clinical experts.
What makes us special:
- In-depth expertise on IVDR, ISO 13485, UDI and performance evaluation
- Operational implementation strength directly from IVD practice
- Experience with Notified Bodies, EUDAMED, FDA and global market access
- Consulting that integrates into your processes - strategically and operationally
Our services can be flexibly adapted to your project requirements: All models are modular, scalable and tailored to IVDR and ISO requirements.
We advise:
- Manufacturer of classic IVDs, companion diagnostics or software as an IVD
- Start-ups with a focus on CE marking according to IVDR
- SMEs with challenges in labeling, UDI or technical documentation
- International companies with market access plans in the EU and worldwide
Yes - we offer IVDR, FDA and UK regulatory readiness programs, inclusive:
- Mock audits and document review
- Support with notified body communication
- Assistance with EUDAMED registrations
- Support with Q submissions or pre-sub meetings
- Response to CAPAs or findings
- Kick-off & target definition
- Gap analysis (e.g. for IVDR, QMS or labeling)
- Project planning with clear responsibilities
- Implementation in close coordination with specialist departments
- Conclusion with review, lessons learned and documentation
Our projects range from a few weeks (e.g. PER creation) to system or approval projects lasting several months.
We work in a transparent and goal-oriented manner:
- Project-related offers or daily rates
- No hidden additional costs
- Interim options for staff shortages
Yes - online or on site. Examples:
- IVDR basic training
- Creation of Performance Evaluation Reports (PER)
- PMS and PMPF training courses
- Labeling & UDI workshops
- CSV & Data Integrity for software-based IVDs
Yes - we can provide support for audits, requests from authorities, PER creation, labeling issues or data maintenance (UDI/EUDAMED) within 48 hours - nationally and internationally.
