Design Control is an integral part of any quality system in regulated industries. FDA Quality System regulation, Quality System Inspection Techniques (QSR and QSIT) and ISO 13485: 2016 have specific product verification and validation requirements that must be fulfilled in the medical device industry. FDA is getting more and more stringent about product design requirements for risk management and to fulfill its mandate for safety and efficacy of all medical devices.
The design controls are now being expected from outside equipment manufacturers (OEM) and all suppliers to the medical device industry. This webinar will educate you on the key areas that you need to focus on to fulfill the design control and testing requirements for your medical device at various phases of your product development.
AREA COVERED
- Product development process overview
- Applicable design verification and validation requirements
- Testing requirements including the pertinent ISO Standards
- Translation of user requirements into design inputs
- Role of testing and regulatory requirements
- Focusing on critical to customer and quality requirements
- Design verification and design validation activity cycles
- Traceability and risk management at all stages
- Design outputs and documentation in DMR (Device Master Records) and DHR (Device History Records)
- Proof for how design outputs meet functional and operational requirements
- Compatibility of the design with components and other accessories
- Test requirements to fulfill acceptance criteria for final products
- How to withstand regulatory scrutiny
- How are changes and their effects controlled and documented during the device life cycle?
- Summary
WHO WILL BENEFIT?
- Senior management
- Middle management
- Research & Development
- Quality Engineers
- Manufacturing Engineers
- Regulatory Affairs Professionals
- Quality Assurance & Quality Control Personnel
- Device Design Team
- Device Development Team
- Device Manufacturing Team
- Verification and/or Validation planning, execution and documentation for devices.
- Start up Company Leaders
- Product development process overview
- Applicable design verification and validation requirements
- Testing requirements including the pertinent ISO Standards
- Translation of user requirements into design inputs
- Role of testing and regulatory requirements
- Focusing on critical to customer and quality requirements
- Design verification and design validation activity cycles
- Traceability and risk management at all stages
- Design outputs and documentation in DMR (Device Master Records) and DHR (Device History Records)
- Proof for how design outputs meet functional and operational requirements
- Compatibility of the design with components and other accessories
- Test requirements to fulfill acceptance criteria for final products
- How to withstand regulatory scrutiny
- How are changes and their effects controlled and documented during the device life cycle?
- Summary
- Senior management
- Middle management
- Research & Development
- Quality Engineers
- Manufacturing Engineers
- Regulatory Affairs Professionals
- Quality Assurance & Quality Control Personnel
- Device Design Team
- Device Development Team
- Device Manufacturing Team
- Verification and/or Validation planning, execution and documentation for devices.
- Start up Company Leaders
Speaker Profile

Meena Chettiar completed her education in India, Canada, and the United States where she completed master’s degrees in applied chemistry, Chemical Engineering, and Regulatory Affairs for Medical devices respectively. Meena has worked for Health Canada and Agriculture Canada as a Scientist and Quality Control Chemist. After immigrating to the United States Meena worked for Land O’Lakes and key Pharmaceutical and Medical device Companies such as Cephalon, Baxter, and Covidien in Minnesota, USA. Meena recently transitioned from serving as a Quality Director for Welly Health to the Head of Quality at a Cosmetic Company in the DC area.Meena currently also serves …
Upcoming Webinars



Fair Lending in 2025: New Regulations, Examinations and Enf…

I-9 Audits: Strengthening Your Immigration Compliance Strat…

Using Emotional Intelligence to Elevate Your Leadership

ChatGPT & HR: How HR Recruiting Professionals Can Leverage …

Elevate Your Workplace Wellness: 10 Critical Wellness Facto…

FDA Trends in Compliance and Enforcement in Computer System…

Tattoos, hijabs, piercings, and pink hair: The challenges …

How to Manage the Legal Landmine of the FMLA, ADA and Worke…

How to Write a Successful Job Hazard Analysis


How to Write Right for Better Business Communication

How to Prepare For and Host a FDA Inspection and Respond to…

From Good to Great: The Secrets to an Optimized LinkedIn Pr…

Public Speaking: Overcoming The Fear of Public Speaking



Transforming Anger And Conflict Into Collaborative Problem …

Policy Pops: Navigating DEI in the 2025 Workplace: Strategi…

The Five Cs Of Commercial Credit: The Basic Elements Of Cre…

Workplace Investigations 101: How to Conduct your Investiga…

Navigating Alcohol and Drug Addiction Protections Under the…





Reduce Stress in the Workplace: Effective Ways to Handle Co…

Transforming HR with AI: Unlocking Excellence and Innovation

Creating Employee Handbooks that Protect You and Support th…

FDA Technology Modernization Action Plan (TMAP) and Impact …


Transform Data into Insights: A Beginners Guide to Excel Pi…

50+ new Excel features so far this decade

Mindful Communication:The Key to Meaningful Conversations i…


FDA Proposes Framework to Advance Credibility of AI Models

FMLA Compliance in 2025: A Comprehensive Guide & Strategies…

Excel - 10 Key Worksheet Functions to Skyrocket Your Produc…

Hiring and Retaining Employees in this Crazy Economy

Managing Toxic Employees: Strategies For Leaders To Effecti…

Harassment, Bullying, Gossip, Confrontational and Disruptiv…