ザルトリウス・ジャパン Official site

Sartorius Solutions for Medical Device Quality Management (English Document)

Biocompatibility evaluation, microbial management, dosage accuracy assessment, response to data integrity.

This document introduces Sartorius's proposal for quality management solutions aimed at medical device manufacturers, utilizing products such as the Cubis III laboratory balances, Arium ultrapure water systems, Microsart microbiological testing products, MD8 Airscan, and Vivaspin. It comprehensively supports the entire process from research and development to raw material testing, in-process control, and final shipment testing. In particular, it emphasizes strengths in biocompatibility assessment, microbial management, dosage accuracy evaluation, and data integrity, assisting in the improvement of safety, quality, and regulatory compliance of medical devices. Please feel free to download and read it. [Contents (excerpt)] ■Check Coatings - Applications of Correct Amounts ■Density Check of Solid Material & Liquids ■Gravimetric Dose Accuracy Assessment ■Counting with Reference Weight *For more details, please download the PDF (English version) or feel free to contact us.

Related Link - https://www.sartorius.co.jp/jp

basic information

For more details, please download the PDF (English version) or feel free to contact us.

Price range

Delivery Time

Applications/Examples of results

For more details, please download the PDF (English version) or feel free to contact us.

catalog(12)

Download All Catalogs

Best-Fit Solutions for Medical Device Quality Control

TECHNICAL

The Importance of Secondary Suppliers in Sterility Testing (USP <71> | EP 2.6.1 | JP 4.06 Compliance)

PRODUCT

Ultra-Pure Water Production System "Arium Mini Extend Series" Product Catalog

PRODUCT

Sterisart Universal Pump - 4th Generation Product Data Sheet

DOCUMENT

Sterisart Universal Pump - 4th Generation Product Catalog

PRODUCT

Picus 2 Electric Pipette Product Data Sheet

DOCUMENT

"Quintix Pro" Laboratory Balance Product Catalog

PRODUCT

"Picus 2" Electric Pipette Product Catalog

PRODUCT

Cubis II Ultra High Resolution Balance Sample Holder [Product Catalog]

CATALOG

Zartorius Explosion-Proof Paint Balance Series

PRODUCT

Premium laboratory electronic balance "Cubis III"

TECHNICAL

From Contamination to Compliance: The Role of Sartorius' Laboratory Pure Water and Ultrapure Water Production Systems in PFAS Detection

PRODUCT

Recommended products

Distributors

Sartorius is a leading global company that contributes to biopharmaceutical research and the biopharmaceutical industry, established in 1870. Sartorius's laboratory products/services division meets the needs of researchers and technicians engaged in research and development and quality control in the medical industry and various other sectors by providing innovative laboratory equipment and consumables. Our products and technologies are designed to simplify our customers' operations and contribute to accelerating research and improving operational efficiency. *Biotechnology-related products can be found at the following URL: https://premium.ipros.jp/sartorius-stedim/