Consulting
Strategic consulting for the laboratory business — from idea to operational launch
Consulting areas
Professional expertise for the medical and laboratory business in Germany, the EU, Central Asia and the Caucasus
Opening a clinical diagnostic laboratory
Full support for launching a laboratory in Germany and the EU: from regulatory requirements to the operational start. ISO 15189 accreditation, DAkkS, staff, equipment.
- Registration and licensing
- DAkkS / ISO 15189 accreditation
- Selection of equipment and staff
Business development and scaling
Strategic consulting for medical companies: optimising business processes, entering new markets, expanding the service portfolio and increasing profitability.
- Market and competitor analysis
- Scaling roadmap
- Operational process optimisation
Alternative business models
Development of innovative models: B2C walk-in, B2B contracts with clinics, corporate check-up programmes, specialised panels.
- B2C and B2B models
- Corporate programmes
- Specialised panels
Investment analysis and ROI
Preparation of investment memoranda, financial modelling (CAPEX/OPEX), scenario analysis, break-even and IRR calculations.
- CAPEX/OPEX modelling
- Scenario analysis
- Investor memorandum
Regulatory framework
Navigating German and European regulatory requirements: Rili-BÄK, MDR/IVDR, GDPR, staff requirements, quality standards.
- Rili-BÄK / ISO 15189
- MDR/IVDR compliance
- GDPR and data protection
Risk management
Development of a risk matrix with assessment of probability, impact and mitigation measures. Regulatory, operational, financial and competitive risks.
- Risk matrix
- Mitigation measures
- Due diligence
Operational services
In addition to strategic consulting, we provide practical support at every stage
FAT and SAT testing
Factory acceptance testing (FAT) at the manufacturer and site acceptance testing (SAT) at the customer site, with protocol preparation.
Equipment validation
IQ/OQ/PQ validation of medical and laboratory equipment in accordance with ISO 15189 and GMP.
Staff training
Professional development programmes for laboratory technicians, engineers and laboratory managers.
Entering the EU market
Helping companies from Central Asia and Eastern Europe navigate the European regulatory landscape.
How we work
Initial consultation
Analysis of your goals, experience and resources. Definition of the project scope.
Regulatory audit
Assessment of regulatory requirements and development of a compliance strategy.
Business plan and model
Financial modelling, CAPEX/OPEX, scenario analysis, ROI.
Investor documentation
Preparation of the memorandum, due diligence, term sheet.
Operational launch
Support with procurement, hiring, accreditation and the start of operations.
Launching a clinical laboratory in Germany
Anonymised case — a KombiMED consulting project
A team with 15 years of experience in clinical diagnostics in Central Asia approached KombiMED to transfer their expertise into the German regulatory and business environment.
360–725k EUR
Investment request
18–28 months
Break-even
14–22%
IRR (5 years)
1.1–1.45M EUR
Target revenue (Year 3)
Regulatory analysis
German legal and quality requirements: Rili-BÄK, ISO 15189, MDR/IVDR, recognition of qualifications, DAkkS accreditation
Start-up roadmap
12–18 months: legal registration, staff recruitment, quality management, equipment, pilot launch
Investment model
CAPEX, OPEX, working capital, three scenarios (pessimistic, realistic, optimistic)
Investor memorandum
A ready document for negotiations: market opportunity, financial model, team, risks
CAPEX structure (example for 250 m²)
IVD equipment
Analysers, archivers, automation systems
Renovation and zoning
BSL-2 ventilation, deionised water, laboratory finishing
IT / LIMS
Laboratory information system, GDPR infrastructure
Accreditation
ISO 15189, DAkkS audit, external quality assessment
Reserve
Contingencies and buffer fund
Our digital platforms
Interactive tools for self-assessment and planning of a laboratory project
Ready to discuss your project?
Our team, with 25 years of experience in the medical business, will support you at every stage — from the first idea to a successful launch.
Consulting for projects in Kazakhstan, Uzbekistan, Ukraine, Georgia and other countries in the region