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?
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