#Germany #Medical Devices #Hohenstein Laboratories #GLP Certification #Boennigheim

Hohenstein Medical's Commitment to Quality in Medical Device Testing

Hohenstein Medical, part of the esteemed Hohenstein Laboratories, has proudly announced its recent certification to conduct medical device testing in accordance with the internationally recognized Good Laboratory Practice (GLP) standard. This significant achievement not only underscores Hohenstein Medical's expertise in the field but also expands its ability to support medical device manufacturers in navigating the intricate landscape of international regulatory frameworks.

Understanding GLP Certification

GLP certification is pivotal in ensuring that the non-clinical laboratory data submitted to regulatory agencies is of the highest integrity and reliability. The GLP standards are designed to ensure that health and environmental safety studies are systematically organized, executed, and documented. In the context of medical devices, these standards are essential as they dictate the quality assurance processes, ensuring traceability and compliance across various domains, including personnel, facilities, materials, and data archiving. The stringent requirements outlined by GLP reflect Hohenstein's commitment to excellence and to providing clients with accurate, timely, and trustworthy results.

Meeting Industry Demands with Expertise

Dr. Timo Hammer, CEO of Hohenstein, emphasizes the critical role his team plays in supporting clients who produce life-saving medical devices. 'Our customers depend on us for accurate results, timely delivery, and expert guidance,' he stated. By adhering to GLP standards, Hohenstein Medical aims to build trust with its clients, giving them confidence that their regulatory expectations are met, particularly in important areas of chemical, physical, and biological safety testing.

Hohenstein Medical's capabilities extend to conducting biocompatibility testing for various medical devices, encompassing chemical screenings, biological in-vitro tests, and microbiological evaluations, such as bioburden assessments and barrier effectiveness studies. The GLP-compliant data generated at Hohenstein is not only recognized by regulatory authorities globally, including the U.S. Food and Drug Administration (FDA), but is often a prerequisite for product approvals in major markets.

Enhanced Digital Storage and Compliance

In its commitment to uphold the highest standards of data management and accessibility, Hohenstein has developed a state-of-the-art digital system for storing GLP-relevant data. Moreover, a controlled climate paper archive has been established at Hohenstein's headquarters in Boennigheim, Germany, ensuring that all testing data is readily available and meticulously preserved.

Dr. Hammer expressed his satisfaction with achieving this certification alongside their existing ISO 17025 accreditation, stating, 'Meeting the criteria for GLP certification elevates our credibility, fostering global comparability and acceptance of our test results.'

Conclusion: A Step Forward for Medical Device Testing

As Hohenstein Medical becomes GLP certified, it signifies a crucial development not just for the company, but for the medical device industry at large. This achievement enhances Hohenstein's position as a reliable partner for manufacturers who are faced with the complex regulatory requirements of bringing safe and effective medical devices to market. With over 75 years of scientific experience, Hohenstein remains dedicated to driving innovation and reliability in medical testing, ultimately contributing to the advancement of healthcare.

For more information about Hohenstein Medical and its services, you can visit Hohenstein.US/Medical.

About Hohenstein

Hohenstein is a prominent provider of independent testing, research, and certification services, specializing in medical devices, textiles, and consumer goods. With a steadfast commitment to quality and over 75 years of experience, Hohenstein supports manufacturers, suppliers, and regulatory bodies by offering data-driven insights necessary for ensuring product safety, quality, and performance.