ChooSE the Learning Option that is right for you

4 classes, approximately 90-120 minutes each, generally held on Sat mornings.  If you have a group of colleagues interested we can work on a timing that suits you.

Content covered

1. Introduction to Medical Devices 

• Industry overview
• Key roles and responsibilities of various stakeholders
• How big strategics function

2. Understanding the FDA Quality System

• Learn the rules of the game

3.  Understanding Design Controls  

• Part I - How to develop your design, test it and ensure you are building the right product
• Design Verification, Design Validation

4.  Understanding Design Controls 

• Part 2 - How to consistently manufacture world class product
• Process Validation
• Preparing for launch
• Post launch activities to sustain the product

 A certificate is provided upon completing all 4 classes and completing a quiz 

We provide a complimentary 20 minute consultation with additional engagements for a very nominal fee if we both see each other as a mutual fit

• For Innovators:  Reviewing present state, actionable suggestions for next steps, developing strategic project product roadmaps, making high quality introductions to industry experts.  
• For students/ mid career professionals : Suggesting career options, Resume review, mock Interviews with feedback, general mentoring on US corporate culture, communication tactics, teamwork, conflict resolution etc.