Med Device and Med Tech Startups: Master Regulatory Basics and More! September 22 in Philly

We all gotta start somewhere... and Pennsylvania Bio and Quorum have helped us put together an invaluable event to help your early-stage medical device company hit the ground running. Seasoned experts, such as R&Q's President Maria Fagan and Buchanan Ingersoll & Rooney's Will Garvin will be presenting content and answering any and all of your questions and curiosities (you have the chance to submit them in advance during registration).

The Regulatory 101 for Medical Device And Med Tech session is September 22 in Philadelphia and we encourage you to register early!

What will I  learn?

Apart from core regulatory principles, the event will cover the areas of quality systems, design assurance, product quality and post-market surveillance. A special 201 advanced regulatory section will also be offered, along with an "ABC's" for startup and small companies session. Seasoned regulatory and quality professionals are most certainly also welcome (learning about current trends and picking the brains of industry experts never goes out of style). Junior regulatory and quality staff and medical device development and manufacturing staff can also benefit from attending.

What's more, we really want to know what you want to know!

When registering, you have the opportunity to submit a question, scenario, or curiosity you have. This the perfect opportunity to receive expert advice on just about anything in the space.

What's going on in your world right now that you don't understand?

What's the one thing you want to walk away with from the day?

What's your biggest roadblock?

By giving us insight ahead of time, we'll be prepared to attack your needs head on. We strongly encourage you to take advantage of this opportunity in order to get the most out of the day.

So, show me that agenda.
The agenda may change slightly between now and the date of the event, but the following topics will be covered.

8:30 – 9:00
Arrival, light breakfast/coffee, and networking

9:00 – 9:05
Program Intro from Patrick Hayakawa, Director of Member Relations, Pennsylvania Bio

9:05 – 9:30
Regulatory Overview from Theresa Miles, Director of Client Solutions, R&Q

9:30 – 9:55
Quality System Overview from Maria Fagan, President, R&Q

9:55 – 10:20
Design Assurance Overview from Ryan Kasun, PMP, Project Engineer R&Q

10:20 – 10:35
Break and networking! Hear what your peers have to say.

10:35 – 11:00
Regulatory FDA Focus from William Garvin, Shareholder, Buchanan Ingersoll & Rooney PC
William Garvin’s presentation will discuss the scope of FDA’s regulation and how companies are navigating FDA’s boundaries  in order to develop products that provide the greatest return while lowering the regulatory burden on the products.This presentation will discuss such issues as the development of Laboratory Developed Tests, Mobile Medical Apps, Wellness Devices, and Genetic Tests along with understanding important issues for start-up medical device companies.

11:00 – 11:25
Product Quality Overview from Ryan Kasun, PMP, Project Engineer, R&Q

11:25 – 11:50
Post-Market Overview from Theresa Miles, Director of Client Solutions, R&Q

11:50 – 12:15
Lunch and networking!

12:15 – 12:45
Spotlight: Regulatory 201 – A Deeper Dive from Maria Fagan, President, R&Q

12:45 – 1:15
The Regulatory ABC’s for Start-up and Small Companies

1:15 – 1:30
Final Q&A (submit any questions at registration?) and Wrap Up

What's my next step?

It's easy! Register here. Startup company or not, a lifetime of regulatory advice in a day's worth of time is a tough opportunity to pass up. We hope you'll join us.