Navigating Complex Discussions with Regulators
“Navigating Complex Discussions with Regulators” March 2024 Medical Device Playbook webinar is now available on demand.
Delve into strategic perspectives with regulatory experts, Golddy Kaur, a veteran in MedTech leadership, and Shifra Hoch, a seasoned regulatory affairs consultant with Playbook founder, Scott Phillips.
Gain insights into:
- Journey to Commercialization
- Create a Focus
- Effectively managing regulatory challenges
- Pre-Submission Meeting Questions
- Leveraging regulatory challenges as catalysts for growth and success.
Presenter Bios
Golddy Kaur
Golddy Kaur has more than three decades of MedTech experience and held many positions including executive leadership roles. She has experience across general business management, strategy development, commercial functions, operations, engineering, quality, regulatory & clinical research. She possesses a unique blend of Med-Tech industry subject knowledge and business/financial acumen.
As part of the executive leadership roles, she coached a diverse group of individuals and personalities. She has a proven track record in consistently delivering business results, bringing innovations globally through research to commercialization stages, developing talent, and building winning teams. She focuses on achieving personal greatness and finding greatness in others to achieve business goals.
Golddy has a Bachelor’s degree with a major in biology and physics from Ranchi University, India. She started her MedTech journey in 1990 at C. R. Bard, Mississauga. She continued her education by attending several professional development programs in Canadian and US Universities including the Executive Development Program at the Kellogg School of Management, Northwestern University.
Shifra Hoch
Medical Device Playbook is one of North America’s largest MedTech events for entrepreneurial companies and medical device professionals. Designed to inform and inspire medtech and biotech entrepreneurs, Playbook brings you stories and insights from some of the industry’s most remarkable entrepreneurs and seasoned experts.
StarFish Medical provides award-winning design, development, commercialization, and flexible manufacturing outsourcing services —100% dedicated to the medical device and life science marketplace. StarFish Medical partners with innovative companies to create and manufacture breakthrough products for a full range of medical specialty areas including: Digital Health, Cardiovascular, Neurology, Urology, Gastroenterology, Otology, Ophthalmology, and In-Vitro Diagnostics.
StarFish Medical’s technical expertise includes electronics, mechanical, software/firmware systems engineering, in addition to industrial design and human factors. Regulatory Affairs (RA) and Quality Assurance (QA) consultants at StarFish Medical provide regulatory assistance for FDA, CE Mark and Health Canada submissions. Services include QA support for setting up QMS for start-up companies with implementation at the client’s site, and assisting with ISO 13485 certification audits.
Empowering MedTech Innovation®. www.starfishmedical.com
Contact Patrick Dean, Director of Marketing, for media inquiries.