The marriage of mobile applications to medical devices is the latest and will be a future trend in medical devices. The scenario could be developing an APP to allow access to your device. It it could be developing and APP that turns a smart phone into a medical device, or it could be standalone APP that other persons can use with their medical device. Or maybe your APP is not a medical device at all. In developing your computer application, it is critical that you know the FDA enforcement strategy and perhaps adjust your plan to avoid FDA, or plan in the time necessary to develop the information needed for FDA review.
You will learn the latest information on FDA’s enforcement approach for computer based medical devices and applications.
Regulatory Affairs, Quality Assurance (Managers, Directors, Vice Presidents), Legal Counsel, Consultants to the FDA regulated industries
You will learn the latest information on FDA’s enforcement approach for computer based medical devices and applications.
Regulatory Affairs, Quality Assurance (Managers, Directors, Vice Presidents), Legal Counsel, Consultants to the FDA regulated industries
J.Lawrence Stevens
Mr. J Lawrence Stevens has over 20 years of FDA experience encompassing virtually all of the FDA field positions. Also Mr. Larry has eighteen years of industry experience as a mid-level manager and senior executive in clinical, regulatory, and quality in the medical device industry. Mr. J Lawrence has personally designed quality systems, prepared regulatory submissions (510(k), IDE and PMA) and managed 7 multi-center clinical trials for class 3 medical devices. From 1989-1993, he was the Industry Representative on the FDA Circulatory Systems panel. Finally, he is a seasoned educator/speaker with over 250 public presentations to audiences ranging from senior …
Female to Female Hostility @Workplace: All you Need to Know
Maximizing Productivity with ChatGPT: AI Solutions for HR, …
2-Hour Virtual Seminar on Empowering Presentations with Pow…
Pivot tables beginner to advanced + 20 advanced Pivot table…
Understanding Artificial Intelligence (AI) & using Chat GPT
Creating Loyal Customers Through Excellent Customer Service
Understanding and Communication New Immigration Policies (2…
Navigating Talent Management and Retention Strategies.
HIPAA is Unsettled – Safe Compliance Strategies
Project Management for Non-Project Managers - Scheduling yo…
How to Prepare For and Host a FDA Inspection and Respond to…
Empowering Conflict Resolution: Letting Go to Gain Control
Onboarding Best Practices for 2025: Proven Strategies to Po…
Navigating 2025 Employment Laws: What Every Employer Needs …
Managing Toxic Employees: Strategies For Leaders To Effecti…
How to Conduct Exit Interviews - Implementing and Enhancing…
Adapting to Change: Strategies for Personal & Team Resilien…
Introduction to Excels Built-In Solver – Advanced Decision-…
How to Manage the Legal Landmine of the FMLA, ADA and Worke…
FDA Technology Modernization Action Plan (TMAP) and Impact …
Design Control for Medical Devices Including Verification/V…
Stress, Change And Team Resilience Through Humor: An Intera…
Developing and Implementing Quality Culture in the Organiza…
GROUPBY and PIVOTBY functions. Pivot table killers?
Negotiating Skills For Professional Results - Winning Strat…
Use the power of AI to turbocharge your MS Excel
Trust in Leadership: Building and Maintaining Trust as a Le…
Conquer Toxic People - Learn To Protect Yourself And Get Yo…
Excel - Pivot Tables - The Key To Modern Data Analysis and …
AI and Human Resources: The Great Opportunity!
Tools and Tactics for Grieving, Surviving, and Thriving in …
Bootcamp for New Managers and Supervisors: Develop These Es…
How To Conduct An Internal Harassment And Bullying Investig…
How Generative AI can be used in Banking Risk and Compliance
Creating Employee Handbooks that Protect You and Support th…
Excel Power Skills: Master Functions, Formulas, and Macros …
Emotional Intelligence: Mastering the Emotions of Great Lea…
Managing Toxic & Other Employees Who Have Attitude Issues
The Five Cs Of Commercial Credit: The Basic Elements Of Cre…
SOPs - How to Write Them to Satisfy those Inspectors
Improving Employee Engagement & Retention Through Stay Inte…
How to Give Corrective Feedback: The CARE Model - Eliminati…