Bhargava Consulting Group is a leading consulting firm that provides a full range of regulatory affairs services to help clients navigate the complex regulatory landscape. Their experienced team of consultants can provide specialized advice to ensure compliance and success with all global regulatory requirements.
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.
Developing the optimal regulatory strategy depending on the device and market you want to enter.
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
BCG guides you with the selection of the correct Notified Body for your specific device.
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