WELCOME TO OUR
BUSINESS PARTNER AREA
Ratecard
Corona Rate Card
Rate Card for Audit projects
Nilofar Suha
1.120,- EUR / day (1.600,- EUR/ day)
1.200,- CHF / day (1.680,- CHF/ day)
1.280,- EUR / day (1.760,- EUR/ day)
1.360,- CHF / day (1.840,- CHF/ day)
Anne Woitzik
1.120,- EUR / day (1.600,- EUR/ day)
1.200,- CHF / day (1.680,- CHF/ day)
1.280,- EUR / day (1.760,- EUR/ day)
1.360,- CHF / day (1.840,- CHF/ day)
Lukas Geppert
1.120,- EUR / day (1.600,- EUR/ day)
1.200,- CHF / day (1.680,- CHF/ day)
1.280,- EUR / day (1.760,- EUR/ day)
1.360,- CHF / day (1.840,- CHF/ day)
Diana Lämpe
1.280,- EUR / day (1.760,- EUR/ day)
1.360,- CHF / day (1.840,- CHF/ day)
1.440,- EUR / day (1.920,- EUR/ day)
1.520,- CHF / day (2.000,- CHF/ day)
Tanja Rohark (CEO)
1.600,- EUR / day (2.080,- EUR/ day)
1.680,- CHF / day (2.160,- CHF/ day)
1.760,- EUR / day (2.240,- EUR/ day)
1.840,- CHF / day (2.320,- CHF/ day)
NB: Rates listed above exclude all additional charges
Service overview
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Quality Management System ISO 13485, ISO 27001, FDA 820, ICH 10
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QMS Certification, Audit Preparation
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QMS Update - MDD to MDR updates, further product categories
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Audit Management (Supplier Audit, IT Audit, FDA Pre-Approval Inspection, QMS)
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Medical Device Product Launch, CE Marking
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Digital Health Solutions (Health Apps, Health Plattforms IoMT, Software as a Medical Device)
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Software Lifecycle Management IEC 62304, V-Model, Agile, Scrum
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Computer System Validation & Laboratory Equipment Qualification, Validation & Verification, CSV, GAMP 5
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Data Integrity, ERES (21 CFR Part 11, Annex 11
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Risk Management ISO 1497, ICH 8/9
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UX / Usability & Requirement Engineering, Human Factors/Centered, Business Process Analysis, Process Optimization
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Clinical Evaluation CER, ISO
Consultant profiles
Nilofar Suha
Anne Woitzik
Lukas Geppert
Diana Lämpe
Tanja Rohark
Company presentation
Access our company presentation here:
Project References - Selection
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QMS 13485 building & certification, lIfecycle management 62304, technical documentation plus CE Marking
Digital Lab for Health App/SaMD, Fresenius Kabi, Bad Homburg, Germany
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QMS 13485, MDR Update for new process & IT system integration, build up & implementation CSV/Computer System Validation Strategy, Compliance Checks & Audit Preparation, 13485, MDR, MDSAP, FDA,, long term assistance for Global Quality & IT
Karl Storz, Tuttlingen, Germany
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Quality & Compliance, CSV Strategy for laboratories, Data Integrity, ERES, Audit preparation, SwissMedic & FDA Pre-Approval, construction planning for new laboratories, move in to new laboratory facility according to GLP, Pharmacopei, FDA, EMA, ISO 15189
LONZA, Basel & Fresenius Kabi SwissBioSim, Eysin, Switzerland
Next steps - Checklist
Rates accepted
Service contract modell accepted