Industries.
In-Vitro Diagnostics Consulting.
Complex?
Regulated?
Innovative?
Ensure successful diagnostics projects.
IVD Consulting - Your partner for safe & compliant diagnostic solutions.
The in-vitro diagnostics industry is facing extensive regulatory requirements, in particular due to the new European IVDR regulation and FDA requirements. Our experts provide you with comprehensive support for IVDR certification, CE marking and the creation of regulatory-compliant technical documentation to ensure smooth approval.
With customized solutions, we also support you in implementing efficient quality management systems in accordance with ISO 13485, clinical performance evaluation and the digital transformation of your production processes. In this way, we reduce your regulatory risks, optimize your processes and accelerate the market launch of your products.
Optimized solutions for your in-vitro diagnostics.
Regulatory compliance & IVDR approval.
- Advice on IVDR certification for existing & new diagnostic products
- CE marking & technical documentation according to IVDR requirements
- Support with approvals in the USA (FDA 510(k), PMA) & international markets
- Development of IVD-specific quality management systems in accordance with ISO 13485
- Strategic support for the IVDR transition period
Clinical performance evaluation & marketing authorization.
- Preparation & review of Performance Evaluation Reports (PER) in accordance with IVDR
- Support with post-market performance follow-ups (PMPF)
- Development of test protocols & clinical data collection for IVD products
- Support in interactions with notified bodies & regulatory authorities
- Advice on compliance with the requirements for Companion Diagnostics (CDx)
Quality management & production optimization.
- Implementation & auditing of ISO 13485-compliant QMS for IVD manufacturers
- Optimization of production processes for diagnostic test systems
- Validation & verification of IVD test methods
- Supplier qualification & audits to ensure compliance with regulatory requirements
- Introduction of automated quality control systems
Digitization & technology transfer.
- Advice on the introduction of digital diagnostic platforms & AI-supported tests
- Support with the implementation of cloud-based data management systems
- Regulatory assessment of Software as a Medical Device (SaMD)
- Validation of in-vitro diagnostics apps & digital solutions
Discover our Life Sciences expertise.
Research and Development and Engineering
Clinical and Medical Affairs
Quality Management and Operational Excellence
Business Data Solutions & IT Services
Manufacturing and Supply Chain Management
Regulatory and Compliance
Successful consulting projects at IVD Consulting.
Challenge.
An international supplier of IVD products planned to enter the US market and had to overcome extensive regulatory hurdles, including strict FDA regulations.
Measures.
- Carrying out comprehensive due diligence to assess FDA requirements.
- Development of a customized FDA approval strategy for the product range.
- Analysis of the US market and development of a positioning strategy to maximize market potential.
Results.
- Successful FDA approval within 18 months.
- Reduction of market entry time by 30% through targeted market entry strategies.
- Sales growth of 20% in the first year after market entry.
Success.
The company successfully entered the US market and achieved FDA approval in a very short time.
Bring your IVD products safely to market!
Our IVD Consulting services at a glance.
We support you in implementing the complex regulatory requirements of the IVDR (EU) and assist you with CE marking and FDA approval. Our experts help you to identify regulatory risks at an early stage and to design your approval procedures efficiently. In addition to EU and US regulations, we provide you with comprehensive advice on international standards and proactively guide you through the entire approval process to ensure a rapid market launch.
The optimal design of your production processes is crucial for competitiveness and compliance. Our experienced consultants support you in systematically analyzing your development and production processes, identifying weak points and implementing targeted measures to increase efficiency. With well-founded validation and verification strategies, we also ensure product quality and process integrity in accordance with international requirements, in particular ISO 13485 and ISO 14971.
Innovation and speed are the key to success in the dynamic IVD market. Our experts support you in the development and implementation of new diagnostic solutions and ensure a seamless transfer of technologies from the laboratory to industrial production. We provide you with comprehensive support from the feasibility study to product validation and ensure that your innovations are regulatory compliant, safe and ready for the market.
The implementation of a reliable and certifiable quality management system in accordance with ISO 13485 is essential for sustainable market success. Our consultants support you in setting up, auditing and optimizing your QMS to ensure the highest quality standards. In addition, we prepare you specifically for internal and external audits and inspections by notified bodies so that you can meet regulatory requirements proactively and safely.
The integration of digital solutions opens up new potential in diagnostics. We support you in the digitalization of your production and quality processes - from real-time monitoring of diagnostic workflows to the implementation of data-driven decision-making models using software as a medical device (SaMD) and AI-based applications. Our solutions help you to speed up your processes, sustainably increase quality and ensure regulatory requirements for digital health compliance.
We offer you comprehensive support in preparing and updating your clinical performance evaluation (PER) in accordance with IVDR. Our experts support you in data collection, planning and implementation of clinical studies according to international standards, in particular ISO 20916. In addition, we help you to implement a proactive Post-Market Performance Follow-up (PMPF) system to ensure continuous regulatory compliance and product improvement.
Get to know our experts.
Get in touch with our in-vitro diagnostics experts.
Sven Hoffmann
