Licensing & Certifications

Ensuring all necessary licenses and certifications are in place for your medical device is crucial. We provide the expertise to manage these processes, making sure your device meets all the legal requirements for commercialization.

• Manufacturing, Import/Export Licenses:We assist with obtaining required licenses for manufacturing and distribution, including for global markets such as the FDA (USA), CE (Europe), and other regions.

• Test Licenses & Clinical Trials:We guide you in obtaining the required test licenses and approvals to conduct clinical trials for product validation, ensuring compliance with local and international regulatory bodies.

• Sterilization Compliance:We ensure that your device complies with sterilization regulations, such as using validated processes for terminal sterilization, and ensuring appropriate certifications are obtained.