Global Partners LP: Hohenstein Medical Achieves GLP Certification for Enhanced Medical Device Testing
- Hohenstein Medical has achieved GLP certification, enhancing its medical device testing capabilities for international regulatory compliance.
- The certification ensures robust, reliable testing processes, aiding manufacturers in meeting safety and efficacy standards for market approval.
- Hohenstein's expertise supports biocompatibility testing, facilitating innovation and quality assurance in the evolving medical device industry.
Hohenstein Medical Secures GLP Certification Enhancing Testing Capabilities for Medical Devices
Hohenstein Medical, a division of Hohenstein Laboratories, has recently obtained certification to conduct medical device testing in accordance with the internationally recognized Good Laboratory Practice (GLP) standard. This significant achievement allows Hohenstein to provide enhanced services to medical device manufacturers, helping them navigate the intricate landscape of international regulatory requirements. As the demand for compliance in the medical device sector increases, Hohenstein's GLP certification positions the company as a reliable partner in ensuring that products meet the stringent safety and efficacy standards necessary for approval in major markets.
Dr. Timo Hammer, CEO of Hohenstein, underscores the critical nature of this certification, emphasizing the need for accurate results, timely delivery, and expert guidance in the development of life-saving medical devices. With over 75 years of experience in scientific research and international standard development, Hohenstein is well-equipped to assist clients in achieving biocompatibility testing, which includes chemical screenings and microbiological evaluations. The GLP-compliant studies conducted by Hohenstein are recognized globally, including by the U.S. Food and Drug Administration (FDA), making them essential for manufacturers seeking product approvals internationally.
The GLP standard is pivotal in maintaining the integrity and traceability of non-clinical laboratory data submitted to regulatory agencies. It imposes rigorous organizational, operational, and documentation requirements for health and environmental safety studies. By achieving GLP certification, Hohenstein solidifies its existing ISO 17025 accreditation and reinforces its commitment to quality assurance and regulatory compliance. This certification assures clients that Hohenstein's testing processes are robust, reliable, and aligned with global standards, thereby enhancing the credibility of their test results and facilitating smoother market access for medical devices.
In addition to its GLP certification, Hohenstein Medical continues to emphasize its dedication to providing comprehensive support for medical device manufacturers. The company's expertise in biocompatibility testing not only helps clients meet regulatory requirements but also supports innovation in the medical field.
As the medical device industry evolves, Hohenstein Medical's advancements in testing capabilities reflect a proactive approach to quality and compliance, ensuring that manufacturers can confidently bring their products to market while maintaining the highest safety standards. For further information, stakeholders can visit Hohenstein.US/Medical to learn more about the company’s services and capabilities.
