Medical Devices Resources | Sartorius

The Latest Insight on Medical Device QC

High-Quality Solutions for your Medical Device Testing and Quality Control Needs

Learn more about our customized solutions for Medical Devices manufacturing, testing and QC processes will not only improve your productivity, but also ensure full compliance to the most rigorous standards and requirements.

Sartorius solutions enable you to streamline time-consuming, labor-intensive and potentially error-prone manufacturing processes, as well as quality control your workflows.

Featured Resources

Benefits of Using Octet BLI Systems in IVD Product Development cover
White Paper

Benefits of Using Octet® BLI Systems in IVD Product Development

Learn how the Octet® BLI system enables real-time, label-free, high-throughput monitoring of antibody-antigen interactions and provides critical...

Webinar

Evidence-Based Approaches for the Biological Safety Assessment of Medi...

2023 guide to medical device quality control and testing
Resource Guide

Guide to Medical Devices Quality Control and Testing

Stay competitive in the medical device market - Improve productivity and meet rigorous compliance standards with products from Sartorius.

Medical Device & IVD Resources by Category

Application Notes

Application Note

Urine Protein Concentration with Vivaspin®

Vivaspin® centrifugal concentrators are important tools for the preparation of urine samples in clinical testing labs prior to IVD. Find out why!

surfactants selection guide for lateral flow assays
Application Note

Surfactants Selection Guide for Lateral Flow Assays

Find out how different surfactants affect the performance of UniSart® diagnostic membranes during the pre-treatment of sample pads.

Application Note

Fast and Precise Determination of Total Solid Content of Latex

How to develop a method to determine the total solid content of latex in just one minute using the LMA200 microwave moisture analyzer.

Continuous Microbial Air Monitoring in Clean Room Environments
Application Note

Continuous Microbial Air Monitoring in Clean Room Environments

Learn how to benefit from implementing continuous microbial air monitoring to entire manufacturing and QC process of your medical devices.

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Application Note

Ultrapure Water for HPLC Analysis

Evaluates an alternative to commercially sold ultrapure water for the preparation of high-purity eluants for HPLC analysis.

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Application Note

Pipette Calibration and Standards

Pipetting results are critically depending on the maintenance and calibration of the pipette.

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Application Note

How to Avoid Contamination in Pipetting

Preventing contamination during pipetting is paramount to achieving reliable results. Discover three types of pipetting contamination.

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Application Note

The Importance of Accurately Measuring the Moisture Content 

Of Plastic Resin in the Molding Process of Medical Devices

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Application Note

Are You GLP/GMP Compliant When It Comes to Pipetting?

Are you following methods for current Good Laboratory Practice (cGLP) or current Good Manufacturing Practice (cGMP)? 

Application Note

Improved Sample Preparation for HPLC Analysis

HPLC sample preparation is easier than ever with Sartorius’s Cubis® MSA Dosing System.

Octet RH16 with Lab Tech
Application Note

Converting ELISA Assay Into Octet® Quantitation Assay

Key steps for ensuring successful conversion of an ELISA-based assay to the Octet®, including defining the assay requirements, selecting the biosensor...

Articles

Biological Compatibility in Medical Device Development
Article

ISO 10993: Ensuring Biocompatibility in Medical Devices

Download now to discover the latest biocompatibility standards and risk management practices related to the ISO 10993 standard series.

Article

How Can You Let Your Diagnostic Target Analyte Shine?

In this Xtalks Spotlight, two diagnostics experts from Sartorius discuss the challenges and solutions facing the diagnostics industry.

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

EU GMP Annex 1

Impact on Air Monitoring Program for Medical Devices Manufacturers

Brochures

UniSart Nitrocellulose Membranes
Brochure

UniSart® Nitrocellulose Membranes

The substrate of choice for protein assays

Unisart® Membranes in Lateral Flow Test Platform
Brochure

Tips and Tricks for Product Development

This guide gives you some ideas that might help to improve detection, sensitivity and specificity of your lateral flow assay (LFA).

Brochure

Best-Fit Solutions for Medical Device QC

Solutions for Medical Device Development, Manufacturing and Quality Control - Rapidly Boost Your Productivity

UniSart® CN 180 DX Membrane
Brochure

UniSart® CN 180 DX Membrane

PDF 595.2 KB

Datasheets

Octet R2 datasheet cover
Datasheet

Octet® R2 System Datasheet

PDF 485.0 KB

eBooks

eBook

Fortifying Contamination Control

Biocontamination Control Strategy: FDA insights, cleanroom tips, and barrier tech

A guide to high quality laboratory water ebook cover
eBook

A Guide to High-Quality Laboratory Water

This Sartorius eBook is an informative guide for choosing the right water purification system for your laboratory.

OEM Products and Components eBook
eBook

OEM Products and Components

Discover the Sartorius portfolio of OEM products that offer you the flexibility and customized solutions tailored to your individual requirements

Flyers

Solutions for Lateral Flow Assays and IVD Manufacturers flyer
Flyer

Solutions for Lateral Flow Assays and IVD Manufacturers

PDF 865.8 KB

Guides

Resource Guide

Unisart® CN Membranes Selection Guide for Lateral Flow Assays

In this guide we provide a suggestion for the membrane with the best fit based on the sample and assay type.

Bringing Life-Enhancing Medical Devices Safely and Efficiently to Pati...

This eBook highlights how automated, image-based systems, like CellCelector, are simplifying progress in a variety of research applications.

water purification and dispensing
Application Guide

A Guide to High-Quality Laboratory Water

This guide outlines how to choose the right water purification system for your lab to ensure high-quality lab water. 

Minimizing Risk in Endotoxin Testing cover
Resource Guide

Minimize Risks in Endotoxin Testing

Minimize risks in endotoxin testing with our smart pipetting solutions.

2023 guide to medical device quality control and testing
Resource Guide

Guide to Medical Devices Quality Control and Testing

Stay competitive in the medical device market - Improve productivity and meet rigorous compliance standards with products from Sartorius.

how to achieve optimal weighing cover
Resource Guide

How to Achieve Optimal Weighing Performance

Following the instructions and recommendations, your balance will always provide the best weighing performance and highly reliable results.

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Application Guide

How to Set up Pipetting Quality Control Program for Your Lab

This guide outlines the requirements for in-lab testing program as well as for professional calibration and maintenance services.

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Product Guide

How to Select a Mechanical Pipette

Answering the questions of what needs to be considered when searching for the right pipette for the job.

pipette selection guide
Product Guide

Pipette Essentials: Make Your Choice

Download this pipette selection checklist and find your perfect pipette.

Infographics

Infographic

Strategies to Improve Lab Ergonomics by Using the Right Pipette

Get expert tips on how to improve your well-being in the lab and discover strategies to optimize lab ergonomics by using the right pipettes.

Posters

Poster

Advancing the Use of Octet® Label-Free Bio-Layer Interferometry (BLI)

Discover how Octet® instruments are revolutionizing antibody selection and quality control in LFA and IVD research.

Poster

Top 10 Tips to Avoid Contamination in Pipetting

Download this poster and get 10 tips to avoid contamination.

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Poster

Get the Most Out of Your Electronic Pipette

Download this poster and get valuable insight on pipetting with electronic pipette.

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Poster

How to Clean Your Pipette

Regular cleaning of your pipettes is an essential part of your daily lab workflow in order to avoid contamination.

ABC of Pipette Tip Purity
Poster

ABC of Pipette Tip Purity

Is your lab employing the best pipetting techniques to ensure the avoidance of contamination and error?

Publications

The Impact of IVD Regulations on Manufacturing

Discover why the impact of IVD regulations can’t be overstated and how manufacturers of IVD products can overcome the challenges.

Technical Notes

Technical Note

Lab Weighing: Generic Operating Procedures for Routine Testing

Our series of Generic Operating Procedures provides valuable information about routine testing of lab balances. Discover more!

Webinars

Scienion Technology Printing onto Sartorius Membranes
Webinar

Multiplexing with Unisart StructSure®️ Membranes

Get an overview of the benefits of multiplexing with Sartorius' Unisart StructSure® and an introduction to the currently available products.

Webinar

How Can You Let Your Diagnostic Target Analyte Shine?

In this Xtalks Spotlight, two diagnostics experts from Sartorius discuss the challenges and solutions facing the diagnostics industry.

AACC 2023 OEM Event Sartorius
Webinar

How to Select the Best Antibody-Antigen Pair for Your LFA

Learn of how Octet® systems can be used as quality control platforms to select the best antibodies for your LFA development.

Webinar

Optimizing Diagnostic Sample Preparation Workflows With Ultrafiltratio...

Learn practical strategies to improve your diagnostic sample preparation workflows and diagnostic kit reliability in this on-demand webinar.

OEM Weigh Cells
Webinar

Introduction to High Resolution Integrated Weighing

Discover available products for high-resolution weighing applications and important considerations for integrated solutions.

Webinar

Evidence-Based Approaches for the Biological Safety Assessment of Medi...

White Papers

White Paper

Consistency in Physical Data of Unisart® CN Membranes

Download the application note to learn more about the science behind the high quality of Sartorius Unisart®️ CN Membranes.

Benefits of Using Octet BLI Systems in IVD Product Development cover
White Paper

Benefits of Using Octet® BLI Systems in IVD Product Development

Learn how the Octet® BLI system enables real-time, label-free, high-throughput monitoring of antibody-antigen interactions and provides critical...

white paper cover
White Paper

Cubis® II Pharma Compliant by Design

Download and learn about how Sartorius makes compliance easy with features like audit trails and electronic signatures.

Inspecting Cubis instrument
White Paper

Best Practices Guide: Lab Weighing

Discover practical guidance on weighing in the lab, including calibration, accreditation, legal metrology and correct weighing.

Videos

Sartorius Solutions for the Diagnostic Industry

This video shows you how Sartorius solutions can help your diagnostic target analyte shine.

OEM Membrane illustration
Video

How to Improve Test Performance via Dispenser Setup

This tutorial shows how to improve the test performance of a lateral flow assay by finding the right dispenser setup.

Video

How to Select a UniSart® Diagnostic Membrane for Lateral Flow Assays

This video will guide you through the selection process to ensure you choose the right membrane for your assay.

Video

UniSart® Nitrocellulose Membranes

The Substrate of Choice for Protein Assays

Video

How to Measure Physical Properties of UniSart® Diagnostic Membranes

This video shows you how to measure the thickness and wicking speed of Sartorius UniSart® CN membranes.

medical devices

Medical Device Quality Control

Discover Medical Device Quality Control Solutions for Your Industry