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BUSINESS PARTNER AREA

Ratecard

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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

  • Quality Management System ISO 13485, ISO 27001, FDA 820, ICH 10

  • QMS Certification, Audit Preparation

  • QMS Update - MDD to MDR updates, further product categories

  • Audit Management (Supplier Audit, IT Audit, FDA Pre-Approval Inspection, QMS)

  • Medical Device Product Launch, CE Marking

  • Digital Health Solutions (Health Apps, Health Plattforms IoMT, Software as a Medical Device)

  • Software Lifecycle Management IEC 62304, V-Model, Agile, Scrum

  • Computer System Validation & Laboratory Equipment Qualification, Validation & Verification, CSV, GAMP 5

  • Data Integrity, ERES (21 CFR Part 11, Annex 11

  • Risk Management ISO 1497, ICH 8/9

  • UX / Usability & Requirement Engineering, Human Factors/Centered, Business Process Analysis, Process Optimization

  • Clinical Evaluation CER, ISO

Consultant profiles

Nilofar Suha

Anne Woitzik

Lukas Geppert

Diana Lämpe

Tanja Rohark

Company presentation

Access our company presentation here:

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Project References - Selection

  • QMS 13485 building & certification, lIfecycle management 62304, technical documentation plus CE Marking

        Digital Lab for Health App/SaMD, Fresenius Kabi, Bad Homburg, Germany

 

  • 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

 

  • 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

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Rates accepted

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Service contract modell accepted

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Selection of consultant

Verify availability via phone

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Call directly

Sandra Bochnak

+41 (0) 78 230 30 81

Thank you for your interest and we hope our business partner area could provide you with all necessary information. We always welcome feedback in order to constantly improve our service. If you have any comments please feel free to contact us.

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