Back to All Events

MedDevice Development 1 Day Course

When Wednesday, October 23, 2013 - Wednesday, October 23, 2013
9:00 a.m. - 4:00 p.m. 
Add to Calendar

RSVP by Friday, October 18, 2013 12:00 a.m. 
Where BIOCOM Boardroom
4510 Executive Drive, Plaza 7 
San Diego, California 92121

Click here to Register

Instructor

James Macemon
Mr. Macemon is a medical device executive with extensive experience in diagnostics, critical care, patient monitoring, imaging, and lab products. During his 30+ year medi

cal device focused career, he led numerous Research & Development and manufacturing teams, successfully launching products to aid laboratory and health care professionals and improve patient care.

Currently Mr. Macemon is Vice President of Product Development at nanoMR, leading the development and manufacturing program for a device that will enable pathogen identification from a whole blood sample in less than 2 hours, enabling clinicians to prescribe appropriate antibiotics for their septic patients days sooner than is possible with current technology.

Agenda

MEDICAL DEVICE OVERVIEW 9:00-10:15

Medical Devices Defined

Medical Device Diversity

Industry Sectors

Top Companies

History Of Device Regulation

FDA Approval Pathway: 510(k) & PMA

BREAK 10:15-10:30

MEDICAL DEVICE REGULATION 10:00-10:30

Quality System Regulations (QSR's)

Current Good Manufacturing Practices

Good Laboratory Practices

Good Clinical Practices

Risk Management Plan

Exemptions

Rest Of World Approval Pathways

Special Categories:

Home Brew & Combination Devices

Regulatory Challenges

Diagnostics

Predicates

New Technologies

Clinical Trials

Medical Device Reporting

LUNCH 12:00-1:00

MEDICAL DEVICE DEVELOPMENT 1:00-2:15

Phase I: Market Opportunity Evaluation

Market Analysis

Risk Management Plan

Phase II: Concept Evaluation

Formulation Steps

Feasibility

Phase III: Engineering Design Process

Design & Development

Software Development

Prototyping

Phase IV: Verification

Phase V: Manufacturing Transfer

Documentation

Equipment IQ/OQ/PQ

Biocompatibility

Sterilization

Shipping & Storage

BREAK 2:15-2:30

MEDICAL DEVICE APPROVAL 2:30-3:15

Clinical Trials

Need For A "Gold Standard"

Regulatory Submissions

Business Preparations

Product Launch Preparation

Coding & Reimbursement

COMMERCIALIZATION 3:15-3:45

Manufacturing Scale-Up

Product Launch

Post-Launch Assessment

CURRENT ISSUES 3:45-4:15

The Increasing Role Of The FDA

Why Are The Newest Devices In Europe?

Q&A/REVIEW 4:15-4:30

Get Driving Directions

Planner Wedela Heering

 

Earlier Event: October 19
Beyond the Brew: Oktoberfest