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.
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.
Discover Medical Device Quality Control Solutions for Your Industry
Explore the Process Steps for Ensuring Reliable Quality Controls
Features & Benefits of Partnering with Sartorius
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
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.
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.
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.
Ensure Compliant Weighing Workflows
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.
Active Air Monitoring and Sampling for Clean Room Environments
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.
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.
Your Global Life-Cycle Service Partner
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:
- System qualification (IQ|OQ)
- Calibration services and certificates
- Preventive maintenance
- Service contracts
- User training