Manufacturing & Quality Control for Medical Devices

From R&D to Final Release

Pave your way to market by controlling quality with smart and robust Sartorius solutions. From simple needles, bandages or surgical instruments to complex drug-eluting stents or pacemakers – medical device manufacturing comes with stringent quality, safety and efficacy standards.

Let Sartorius support you in maintaining reliable and risk-mitigated processes, delivering high-quality products and ensuring regulatory compliance.


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Medical Device Manufacturing Workflow

Best-fit solutions assist you through the entire development and production process to fulfill biocompatibility, cleanliness, safety and packaging standards. Benefit from precision weighing solutions, ultra-pure water systems and our expertise in filtration, topped with Data Analytics software for straightforward and reliable QC.

With over 150 years of trusted service and proven innovation, quality and reliability, Sartorius can help you bring your life-enhancing medical devices safely and efficiently to market.

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Discover Medical Device Quality Control Solutions for Your Industry

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Drug Delivery Systems

Safeguard superior quality of your high-tech devices for administering active ingredients safely and effectively.

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Surgical Instruments

High-precision tools engineered and manufactured in compliance with stringent quality specifications.

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Wearables & Disposables

Rely on robust, simple and reliable quality control solutions from raw materials to finished products.

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Implants

Manufacture implants with long-term quality, safety and efficacy supported by straightforward QC solutions.

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Contract Manufacturing & Integration

Build on a reliable partnership with customized solutions tailored to your individual requirements.

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Medical Device Manufacturing Featured Products

Medical Device Manufacturing and Quality Control Products

Cubis II Family

Weighing Solutions for Medical Devices Applications

Precision Weighing Balances for Drug Eluting Stents for Accurate, Reliable Results and Increased Productivity

The Cubis® II analytical balance is designed for high- performance weighing and offers digital workflow management following US FDA data integrity principles (ALCOA). On-board QApps contribute to correct usage by guiding through weighing processes, increasing measurement accuracy, precision and process safety. 

The Pharma Software Application Package supports compliance with FDA 21 CFR Part 11 and EU GMP Annex 11, USP Chapter 41 and includes features like user management, digital signatures, audit trail and minimum sample weight determination.

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Active Air Monitoring and Sampling for Clean Room Environments

Efficient, Reliable, User-Friendly Microbiological Testing Solutions for Medical Devices

Opt for total safety and convenience using Sartorius MD8 Airscan® technology. Collect samples using a single gelatine membrane filter without interfering with zone protection.

Proprietary, USP-approved filters retain the smallest airborne microorganisms, practically ruling out false negative results. Conveniently focus on other tasks as your air sampler eliminates the need for manipulation or changing agar plates. 

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Simplify Lab Water Use

To maximize lab space capabilities, your water system should adapt to your needs. Users need full control over quality parameters at the point of use and the ability to fill containers of different size at the same time.

The innovative and flexible Arium® Smart Station addresses these requirements. Dispense water, in the exact quality and quantities required for your experiments, when and where you need it.

Application Note: Ultrapure Water for HPLC Analysis

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Features & Benefits of Partnering with Sartorius

Trust Your Results

State-of-the-art lab instrumentation with built-in applications and security settings

  • Simplify usability
  • Increase measurement precision
  • Support safe and stable testing processes
  • Reduce probability of human error 
Be Compliant

Sartorius’ equipment ensures compliance to the most rigorous standards and requirements like GMP, EU 2017/745 MDR, ISO 10993, ISO 13485, USP, JP and EP.

Ensure Data Traceability and Integrity

Balances connect seamlessly to user management systems generating traceable results. Software solutions support your documentation compliant to US FDA 21 CFR Part 11, EU GMP Annex 11 and ALCOA.  

Improve Time-to-Market with Data Analytics

Optimize your process, identify important correlations or diagnose root causes of problems to significantly reduce experimental costs, de-risk projects and increase success rates. Achieve your quality goals and Quality by Design (QbD) requirements. 

Medical Device Resources

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Featured Resources

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Resource Guide

Minimize Risks in Endotoxin Testing

Minimize risks in endotoxin testing with our smart pipetting solutions.

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pipette selection guide
Resource Guide

Pipette Essentials: Make Your Choice

Download this pipette selection checklist and find your perfect pipette.

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Resource Guide

2022 Guide to Medical Devices Quality Control and Testing

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Instant Access

Brochure

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

PDF | 5.6 MB
Application Note

An Improved Method to Wash Graphene Prior to Use as a Drug Delivery Vehicle

PDF | 260.6 KB
Sample Preparation for Analytical Quality Control
Brochure

Solutions for Pharmaceutical Sample Prep Quality Control

PDF | 5.3 MB

Your Global Life-Cycle Service Partner

Instrument Service

Ensuring Compliance, Reproducibility and Reliability of Your Results

With our comprehensive range of technical services we  support you in regulated and non-regulated labs to ensure regulatory compliance and the highest accuracy of your analytical results. With our certified and accredited services we guarantee the longevity of your equipment and reduce equipment downtime to limit production losses.

We understand the challenges you face as you strive for compliant, reliable, and accurate laboratory data.

We help you to obtain faster and constantly reproducible results with:

  • Installation
  • System qualification (IQ|OQ) 
  • Calibration services and certificates
  • Preventive maintenance 
  • Service contracts 
  • User training

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