About the Speaker
Paige is a quality management and regulatory professional with 13 years in the medical device industry. Her expertise includes regulatory strategy, product design and development, process validations, V&V, QMS deployment, and auditing to FDA 21 CFR 820 / ISO 13485. She is experienced with complex invasive and implantable devices. Paige assists clients with product design and development of Class II and Class III medical devices, including regulatory submissions and complex process control and supplier strategies. She holds a RAC (Regulatory Affairs Certification) – Devices and is a Certified Quality Engineer and Certified Six Sigma Black Belt.
This training will introduce the different FDA regulatory pathways for medical devices in the US, give an overview of the classification process for medical devices in the US, and discuss the requirements and timelines for each pathway. This training is aimed at anyone involved in design and development or regulatory activities, and especially tailored towards those already familiar with the EU MDR process of device classification.
By attending this training, you will receive an in-depth discussion of the following topics:
The following topics will also be included in the training:
EUR 415 including course material and certificate