Medical Devices

Healthcare technologies are among the most strictly regulated and complex approval processes in the world, from the design phase to commercialization. GTL (Global Technology Laboratory) is your strategic solution partner that manages all testing and validation processes for your active medical devices from a single center. We certify the quality, efficacy, and safety of your products across a wide range, from pharmaceuticals to biotechnology and medical devices.

Comprehensive Testing Solutions for Active Medical Devices
The complex structure of active medical devices requires simultaneous verification of both electrical safety and software integrity. At GTL, we offer the following services to ensure your devices function flawlessly under real-world conditions:

• Electrical Safety and EMC: We ensure that devices do not pose electrical risks to patients and operators and that they operate in electromagnetic compatibility with other medical equipment.
• Software Life Cycle and Safety (IEC 62304): We test all stages of medical device software, from design to updating, according to international standards.
• Functional Safety and Usability: Our experts conduct detailed risk analyses and usability assessments to identify potential hazards arising from mechanical or design errors during use.

Global Standards and Accreditation in Life Sciences
The life sciences sector faces increasingly stringent global regulations. With Element’s decades of experience and GTL’s technical infrastructure, we provide critical data to pharmaceutical, biotechnology, and medical device manufacturers.

• Certified Laboratory Network: We analyze the most sensitive biological and chemical parameters in our GMP, GLP, ISO/IEC 17025, BSL-2, and BSL-3 certified facilities.
• Support from Development to Commercialization: We are with you every step of the way, from validation processes during the product development phase to the final compliance reports required for licensing files.
• Data Integrity and Trust: The accurate and reliable results produced by our rigorous testing protocols accelerate your entry into global markets while providing a competitive advantage.

Why GTL and Element Partnership?
Medical device manufacturers must manage a complex validation process involving mechanical, electronic, and biological parameters. GTL simplifies this complexity for you. With our expertise in TSE and international regulations (MDR/IVDR), we shorten the time to market for your innovative healthcare technologies and ensure they are certified to the highest safety standards.