Licensing & Certifications

Ensuring all necessary licenses and certifications are in place for your medical device is crucial. I 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.