Doing It Right the First Time - Avoiding Medical Device Start-up Pitfalls

This presentation will review key considerations for medical device startups during product development. Topics include connecting regulatory and business strategies, interacting with the FDA and Notified Bodies, and updates on recent industry changes (e.g. ISO 13485, IVDR and FDA regulation updates).

The topics discussed are relevant to experienced medical device professionals as well as those new to the industry. This seminar is designed for those who need a  better understanding of the regulatory requirements surrounding medical devices. Those with backgrounds in the pharmaceutical or biotechnology industries, scientists, engineers and technicians working on device design and development, product managers, business development managers, marketing professionals, QA/QC personnel, regulatory affairs professionals, and investment and acquisition specialists will all benefit from this seminar.

Presenter

Christine Santagate RAC, is the Boston Client Solutions Advisor for Regulatory & Quality Solutions LLC.  Christine’s training and experience consists of extensive experience in Medical Device Quality and Regulatory Assurance with a focus on the product development life cycle.  She has experience with CAPA and complaint systems, design control processes and achieving US and International Regulatory approval (510k, PMA, CE). Christine is also a Quality auditor with wide-ranging experience auditing quality systems against ISO and QSR regulations. As Operations Manager, Christine has overall accountability to oversee company consulting operations to ensure production efficiency, high quality, excellent customer service, and cost-effective management of resources. As a Principal Advisor, Christine acts as a project leader, coordinates and participates in the development, compilation and submission of PMAs, IDEs, and 510(k)s. She also
represents and supports clients in interactions with regulatory authorities.

Register Now!Registration fee until October 14: $10.00
Registration Fee Until October 14, 2015: $20.00
Registration Fee October 20, 2015: $30.00

Registration fee includes Pizza, Beer & Wine!