Medical Device Develpments

Learn OVERVIEW of how to develop and manufacture a medical device in compliance with FDA and International regulations

Phases of medical device development, Medical device safety and compliance, How to train your staff on medical device.

Understand Medical Device Design Control in simple terms to gain market approval. Compliance in the EU, US and Globally.

Become a Medical device development and risk management expert inline with ISO 14971:2019

Learn about the medical device industry and how to bring new products to market 510K, PMA, De Novo, ISO13485 and beyond!

Become a Medical device development and risk management expert inline with ISO 14971:2019

Master the 62304 standard and FDA design controls

FDA, ISO 13485, MDR, Regulatory Compliance, Medical Device Regulations, Global Market Access, Quality Management System,

ISO13485:2016 Training

Best Practices for Compliance and Safety in Medical Device Software