Regulatory Services

Our Regulatory Affairs Services assist clients in navigating the complex and ever-changing regulatory landscape. We specialize in medical devices and IVD medical device licensing, certification, and registration, so you can be sure your product is compliant and ready to go to market. With our expertise in regulatory affairs, we can ensure your product's success in the global marketplace.

Regulations vary depending on the medical device and the market you want to enter. Our team supports you with all necessary regulatory compliance issues worldwide.

• Medical Device Registration

• Preparation and submission of regulatory applications:

• US - FDA 510(k) submissions

• US - FDA Pre-Submission Applications

• Europe - Technical files - CE submission

• Health Canada submissions

• Israel - AMAR submissions

• China - CFDA submissions

• Japan - MHLW submissions

• Korea - KFDA submissions

• Taiwan - TFDA submissions

• Notified Body Selection

• US FDA Establishment Registration for Medical Device Companies

• Evaluation of your device and its materials for biocompatibility compliance

• Planning and Execution of Biocompatibility Studies according to (ISO 10993-1)

• Preparation of Clinical Evaluations

• Preparing risk analysis management files (ISO 14971)

• ETO/Gamma Sterilization Validation

• Shelf-Life Testing, including Accelerated Aging

• Post Market Surveillance Plans & Reports