Grace Bartoo, PhD
Regulatory Lead/Advisor
Grace has more than 25 years of experience in the medical device industry and has spent over 15 years working directly in medical device startups, helping to bring companies from initial funding to full operations. Grace has led a team of quality, regulatory and clinical personnel in providing consulting services for a wide variety of projects including: preparation of 510(k), PMA, CE and Canadian applications; Design History File and Device Master Record preparation; preparation and execution of multi-site clinical studies; establishment and improvement of Quality Systems; conduct of formal Quality System audits and leading FDA/NB inspections; development and execution of device verifications and validations, and software tool validation to comply with 21 CFR 11 and process validation requirements.
