Medical Device Virtual Summit

9:00 am – 10:00 am ET

The Big Three: Cytotoxicity, Sensitization & Irritation Testing

This talk will review the current status of these big 3 tests, what the future holds, and how to problem solve.

1. An overview of the big 3 tests
2. Discussion of the updated 10993-1 2018 and the possibility of a big 5
3. Current regulatory trends for these tests and what the standard committees are working on

Thor Rollins

Director, Toxicology and E&L Consulting at Nelson Laboratories, LLC

10:00 am – 11:00 am ET

Patient Engagement and Software as Medical Device (SaMD): The Coming of Medical-Grade Lifestyle Devices

In this talk, we’ll look into this idea in more depth, examine some emerging success stories, and discuss a variety of the challenges that will have to be overcome by industry leaders to cross this chasm including:

1. The combination of business, regulatory and distribution strategies that can help these products succeed?
2. How remote data collection can play in ensuring the integrity of medical devices taken home by patients that have the potential to improve human health, but also create potential safety and mis-use risks
3. How will device manufactures, providers, and patients collectively balance the possible rewards of data sharing with the risks of high-fidelity data collection tools eroding patient privacy?
4. And ultimately, How can adherence to prescribed treatments evolve from a chore to be completed into various combinations of compelling, engaging, satisfying, social, and even fun?

Bernhard Kappe

Founder and CEO, Orthogonal

Randy Horton

VP of Solutions and Partnerships, Orthogonal

11:00 am – 12:00 pm ET

The ABCs of Medical Device Software Compliance Under EU Regulations 2017/745 and 2017/746

Classification:

1. This presentation will review medical device software (MDSW) classification and implementing rules under the MDR and IVDR. Proper device classification is essential as it determines your conformity assessment route
2. It will also cover application of IEC 62304:2006 to your software life cycle processes, including assignment of a safety class. Early incorporation of these principles can streamline document readiness for your conformity assessment

Technical Documentation:

1. This presentation will cover the key requirements for MDSW technical documentation under the MDR and IVDR, including risk assessment, performance evaluation, and post-market surveillance plans.

April Komplin

Medical Device RA/QA Subject Matter Expert, Celegence

1:00 pm – 2:00 pm ET

Process & Technology Innovation in EU MDR Compliance

1. Identify the requirements of the EU MDR, in particular, ongoing PMS requirements for various reports such as PMCF plans/reports, Clinical Evaluation plans/reports, SSCPs, etc.
2. Understand how businesses are approaching MDR as an opportunity for business transformation
3. Learn to leverage a single source of truth to harmonize data across various documents including your IFU, technical file, and post-marketing documentation
4. View an overview and demo of our cloud-based EU MDR compliance platform which saves 20% of time for our medical device writing team

Shruti Sharma

Senior Medical Writer, Celegence

2:00 pm – 3:00 pm ET

Human Factors Engineering in New Product Development

Designing a solution without considering how someone may use it is potentially dangerous and can (significantly) impact market adoption. Some of the issues we will discuss include:

1. What is human factors engineering?
2. What role does human factors engineering play in the product development cycle?
3. How do you implement it in your product development plan?

Tom KraMer

President and CEO, Kablooe Design