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カタログの抜粋

Target identification, biomarker discovery Market analysis Patent and publication reviews Benefit-risk determination Opportunity and Risk Analysis Collection of appropriate samples Biomarker qualification Prototype assay Assay Feasability Assay qualification Analytical validation Definition of Critical Parameters Robustness of test Contractualization with suppliers 1st and 2nd tier Total Cost of Ownership Design of the test Patient selection, anonymization Diagnostic specificity and sensitivity, analytical and clinical performance Small scale manufacturing Delivery to Clinical centers Clinical Data Filing according to the Quality Management System (QMS), manufacturing, technical description, clinical data, evidence of efficiency, transportation, packaging Premarket approval (PMA) submission Manufacturing, conditioning Quality Control Pricing | cost final decision Supply & retail chain consolidation Stock Delivery Sales Product Launch Life cycle management Reporting Preventive | corrective actions Data | sales volumes | estimates of user population and frequency of use Post market performance follow-up Regular updates and with additional features and capabilities Post Market Surveillance

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Sartorius Groupのすべてのカタログと技術パンフレット

1. 

   Tips and Tricks for Product Development

   4 ページ

2. 

   UniSart ® Nitrocellulose Membranes

   15 ページ

3. 

   Ultrapure Water for HPLC Analysis

   6 ページ

4. 

   Surfactants Selection Guide for Lateral Flow Assays

   8 ページ

5. 

   How to Set Up a Pipetting Quality Control Program for Your Lab

   4 ページ

6. 

   Pipette Calibration and Standards

   4 ページ

7. 

   OEM

   52 ページ

8. 

   Octet® R2 System

   7 ページ

9. 

   Quality Control of Biotherapeutics Using Octet® Systems

   4 ページ

10. 

    The Importance of Accurately Measuring the Moisture Content of Plastic Resin in the Molding Process of Medical Devices

    4 ページ

11. 

    EU GMP Annex 1—Impact on Air Monitoring Program for Medical Devices Manufacturers

    4 ページ

12. 

    2023 Guide to Medical Devices Quality Control and Testing

    9 ページ

13. 

    Best-Fit Solutions for Medical Device Quality Control

    12 ページ

14. 

    Fast and Precise Determination of Total Solid Content of Latex

    6 ページ

15. 

    Are You Compliant When it Comes to Pipetting?

    5 ページ

16. 

    Unisart® CN 180 DX Membrane

    4 ページ

17. 

    Solutions for Lateral Flow Assays and IVD Manufacturers

    2 ページ

18. 

    How to Select a Mechanical Pipette

    5 ページ

19. 

    Pipette Cleaning

    1 ページ

20. 

    Top 10 tips to avoid contamination in pipetting

    1 ページ

21. 

    Minimize Risks in Endotoxin Testing

    8 ページ

22. 

    Get the most out of your electronic pipette

    1 ページ

23. 

    Preparation of Standards – Easier than Ever with the Sartorius Cubis® MSA Dosing System

    4 ページ

24. 

    Cubis® II Pharma Compliant by Design

    6 ページ

25. 

    continuous air monitoring

    6 ページ

26. 

    Pipette Essentials

    2 ページ

27. 

    Contamination in Pipetting

    4 ページ

28. 

    ABC of pipette tips

    1 ページ

29. 

    Vivaflow®

    12 ページ

30. 

    Vacusart

    2 ページ

31. 

    The Sterisart® Universal Pump

    8 ページ

32. 

    Sterisart® Sterility Testing

    6 ページ

33. 

    Sterisart® NF

    4 ページ

34. 

    Sterisart® Family

    12 ページ

35. 

    Speedcal Mobile

    2 ページ

36. 

    Sartocheck® 5 Plus Filter Tester

    26 ページ

37. 

    Sartocheck® 4 plus Filter tester

    4 ページ

38. 

    Rline® Dispenser Module

    4 ページ

39. 

    Quintix® and Secura®

    24 ページ

40. 

    Picus® and Picus® NxT

    8 ページ

41. 

    Midi Plus Pipette Controller

    4 ページ

42. 

    Microbiological QC Solutions

    12 ページ

43. 

    MA160 Moisture Analyze

    8 ページ

44. 

    Low Retention Tips Optimum Flow for Optimum Recovery

    8 ページ

45. 

    Filter Papers

    36 ページ

46. 

    Cubis® II

    12 ページ

47. 

    Achieve Optimal Weighing Performance with Cubis® II

    8 ページ

48. 

    Claristep® Filtration System

    12 ページ

49. 

    Arium® Mini

    11 ページ

50. 

    Ultrafiltration Family

    96 ページ

51. 

    arium® Water Purification Systems

    11 ページ

52. 

    Sartorius Pipetting and Dispensing Products

    86 ページ

53. 

    Midi Plus™ Ergonomic Large-Volume Pipetting

    4 ページ

54. 

    Treatment of Vivaspin® Concentrators

    4 ページ