Medical Device Virtual Summit – Afternoon Program
To review the agenda of the morning sessions, explore here!
- What: Medical Device Virtual Summit
- When: May 25th from 9:00 am – 3:00 pm EST
- Where: Online Event
- How: Register online now
- Why: Make sure you join us for a day of industry insights into the latest trends medical device manufacturers face during the product development life cycle through post-market activities. There will also be Q/A sessions following each of the presentations led by the expert panelists.
About the Medical Device Virtual Summit – 2021
We have planned an informative day with thought-provoking sessions presented by leading industry experts. You can also join to have your questions answered in Q/A sessions with each speaker at the end of their presentations. The virtual summit will be held on May 25th from 9:00 am – 3:00 pm (EST) and you can register to secure your place now.
You will not want to miss Celegence’s first annual Medical Device Summit. We are committed to offering you invaluable content and insights, and our goal is to provide holistic support to the medical device industry. You can read more about the featured speakers and the topics of their presentations below, and we hope that you can join us on May 25th!
Claim Your Free EU MDR Checklist Now!
Make sure you and your business are compliant with the new EU MDR. Get our 23 page checklist for actionable technical documentation requirements.
Afternoon Program – Medical Device Summit Agenda
Presentation #1: Process & Technology Innovation in EU MDR Compliance
- Time: 1:00 pm – 2:00 pm EST
- Speaker: Shruti Sharma
- Position: Senior Medical Writer
- Company: Celegence
About Shruti Sharma
Shruti has 5 years of experience in Medical Writing, specializing in Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Summary of Safety and Clinical Performance (SSCP) Reports and Post-Market-Surveillance Reports (PMSRs). She has been the lead author for Clinical Evaluation Plans and Reports (CEP/CER) for device families across a wide range of therapeutic areas – endodontics, prosthodontics, diagnostic imaging, interventional neuroradiology, cleaning, disinfection and sterilization devices, in addition to Software as a Medical Device (SaMD).
She has also developed comprehensive CEP and CER templates providing detailed instructions for regulatory compliance in multiple therapeutic areas in a range of possible scenarios for the device by leveraging subject matter expertise and previous experience with Notified Bodies.
About the Presentation:
- Demystify the requirements of EU MDR, in particular, ongoing PMS requirements for various reports such as PMCF plans/reports, Clinical Evaluation plans/reports, SSCPs, etc.
- Understand how businesses are approaching MDR as an opportunity for business transformation
- Learn to leverage a single source of truth to harmonize data across various documents including your IFU, technical file, and post-marketing documentation
- View an overview and demo of our cloud-based EU MDR compliance platform which saves 20% of time for our medical device writing team
Presentation #2: Human Factors Engineering in New Product Development
- Time: 2:00 pm – 3:00 pm EST
- Speaker: Tom KraMer
- Position: President and CEO
- Company: Kablooe Design
About Tom KraMer
Tom has been a product innovator for over 28 years, and holds a Certificate in Master of Product Development at Northwestern University and a bachelor’s degree in Industrial Design at MCAD. He also holds a certificate from Stanford University for the Cardiovascular System in Health and Disease. He has created revenue for countless customers by delivering innovative product solutions to their portfolios. Tom spearheaded the D3 Process™ (Design Driven Development™), a vehicle to provide these results to customers, and he teaches this process by traveling as a lecturer and speaking about innovation and development processes across the nation.
About the Presentation:
Human factors engineering is extremely integral to user/market adoption. Understanding some of the tools available on the front end of product development might help you avoid downstream problems, before they become time and money wasters. Human factors engineering is one such tool. Human factors engineering will consider issues such as how people interact with your device so that the product is used correctly—every single time. It may include building in safeguards that prevent misuse, especially important with devices used in life and death environments. Defining the role of human factor engineering within the realm of product development is critical, and the industry can learn from numerous real world examples and case studies.
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:
- What is human factors engineering?
- What role does human factors engineering play in the product development cycle?
- How do you implement it in your product development plan?
Who Should Attend this Summit?
This virtual summit will be of interest to anyone working for companies in the life sciences industry, including manufacturers of medical devices, with a special emphasis on:
- Regulatory Affairs Managers & Professionals
- Quality Assurance Managers & Professionals
- Packaging Development Product and Project Managers
- Technical Writers and Managers
- Operations and Design Managers
- Clinical Affairs Managers & Professionals
- Authorized representatives in Europe
Claim Your Free EU MDR Checklist Now!
Make sure you and your business are compliant with the new EU MDR. Get our 23 page checklist for actionable technical documentation requirements.
Medical Device Virtual Summit Sign Up
The Medical Device Virtual Summit will be held on May 25th, 2021 from 9:00 am – 3:00 pm EST. Register and secure your spot by registering now.
Medical Device Virtual Summit Registration Is Open Now!
Make sure you join us for a day of industry insights into the latest trends medical device manufacturers face during the product development life cycle through post-market activities. There will also be Q/A sessions following each of the presentations led by the expert panelists.
Celegence – Services and Solutions to Support the Life Sciences
As regulatory specialists, we work across all phases of the product lifecycle from regulatory strategy, authoring, and all aspects of established product maintenance, including submission management, publishing and health authority interaction. We leverage a global team of consultants to provide local regulatory insight, strategy and intelligence. We are happy to share our insights with you through the summit and hope that you can join us then.
