Developing an FDA Regulatory Strategy (Part 1)

In this two-part webinar series, R&Q presents the definitive resource for bringing your medical device to market in the United States. Part 1 of the series will address Class I and Class II devices, while part 2 will cover Class III devices and be scheduled for late spring.

Register for part 1 on this page and you'll be notified via email when part 2 is announced.

This webinar is designed to help you create a comprehensive regulatory strategy that enables you to successfully enter the US market.

This webinar is not is a rehash of the regulations (we'll provide references, however).

We'll begin by looking at everything that needs to be included in a thorough regulatory strategy. While viewing the big picture can be daunting at first, it's a critical step to understanding the strategic process and formulating an efficient, cost-effective plan... that works.

Since executing everything at once is challenging, the webinar will not only cover what to do - like properly classifying your device and implementing your quality system - but also when to execute. It also takes into consideration questions such as, "What type of evidence do you need for a 510(k)?" and “What are the pros and cons for Q-subs? Finally, we'll look at potential pitfalls where we've seen clients misstep and how to avoid those situations.

Considering the challenges related to EU MDR, this webinar series may be especially helpful to European companies considering the US as a new market. 

Presenters

Kevin Go, MBA, CQA – Senior Engineer (former FDA)
Regulatory & Quality Solutions (R&Q)

Kevin has experience working in both the public and private sector, as well as various-sized organizations ranging from small start-ups to multi-national corporations. He recently joined R&Q Solutions, after working at FDA for over 5 years. In his time at FDA, he served as a Lead Reviewer in the Division of Orthopedic Devices, where he reviewed numerous pre- and post-market submissions. Additionally, he also served as an Advisor to the CDRH Innovation group and Payor Communication Task Force, where he provided early regulatory and reimbursement assistance to small businesses. Kevin has Bachelor of Science in Biomedical Engineering, a Masters in Business Administration, and CQA certification.

Felicia Hosey, RAC – Senior Principal Specialist
Regulatory & Quality Solutions (R&Q)

Felicia is has worked in the medical device industry for over 15 years acting as a researcher on developmental projects, key product development and regulatory project team member and regulatory consultant to a wide variety of medical device and in vitro diagnostic medical device companies. Felicia is a member of RAPS with a global RAC, which has equipped her with the skills necessary to be successful on projects relating to domestic and international medical device regulations. She is also a member of the R&Q Leadership Council which is responsible for preparing reference tools and templates for use with multiple devices types during EU MDR and IVDR remediation.

Matt Burger, MSEM, CQA – Account Director
Regulatory & Quality Solutions (R&Q)

Matt Burger is a Quality Assurance Professional with over 5+ years leading teams and 12+ years of experience in the Medical Device Industry with a focus in quality related roles, including Auditing.  He is experienced in leading supplier quality, design verification and validation, design quality, risk management, quality management system improvements, FDA remediation activities and compliance to 21 CFR Part 820, ISO 13485, CMDCAS, 93/42/EEC. Matt’s proficiency in managing internal cross- functional teams and driving efficient solutions has enabled him to help clients achieve regulatory and quality compliance and meet continuous improvement objectives.

Matt is one of R&Q’s primary auditing resources and as such has completed numerous audits of medical device manufacturers, suppliers, and contract manufacturers. As a Certified Quality Auditor in the medical device industry Matt has a strong understanding of Quality System and Good Manufacturing Practices (GMP) principles.