CDG — Consulting, contracting, and training for medical devices.

Training
Books, e Conferences, workshops, and CDs or On Demand videos of past events.

Gantt chart for a typical clinical research trial; tasks are plotted against time.
Click on a task to see how CDG can help you. Schedule for device approval  
Biological Safety Biologycal Safety
Market Assessment Market Assessment
Regulatory strategy Regulatory Strategy
Protocol Protocol
Sample size Sample Size
Case report form design Case Report Form Design
Investigator Agreement INvestigators Agreement    
Budget & payment terms Budget and payment terms
Clinical Trials Agreement Clinical Trials Agreement
IRB Review & approval IRB Review and approvalmilestone1  
Initiation, first subject in milestone2
Monitoring close-out las subject out  
Close-out, last subject out milestone3
Database Design Database Design
Data entry, queries Statistical analysismilestone4  
Statistical analysis Regulatory submission, approval  
Regulatory Submission, approval Medical device to market  
TO MARKET

milestone5
Project Management
Training

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cdginc@clinicaldevice.com
CDG: consulting, CRO contracting, and training for medical devices and in vitro diagnostics. We do clinical research, contract research, biological safety, biocompatibility, and regulatory consulting. We offer professional development, clinical trial workshops, and e conferences with guest expert speakers, both public and on-site.
 
CDG's Blog; The Latest Backstory

Choosing a Regulatory Submission Plan

We don't usually associate 'choice' with regulatory submissions. Usually we think of the requirement for a 510k or PMA as being cut and dried--the decision is already made, our job is to figure out what the decision is.

In this e Conference I've invited Janice Hogan (of Hogan an Hartson) to teach us how we, as manufacturers of medical devices, do have choices about our regulatory strategy. The type of submission we need depends on the claims we want to make for the device. The claims we want to make may be influenced by market forces as well as the device's physical performance.

For example, if I have a department full of people who know how to file a PMA, I'll be sure to word my claims so that a PMA is required and I can roadblock for my competitors. But if I'm a start-up firm and getting venture capital is my worry, I'll go after the easy claims first. My primary goal being to demonstrate that I can get a submission through FDA and generate income.

Work with the words...that is part of the message Janice will bring. If you are a regulatory professional in medical devices you should plan to attend this lively and informative e Conference.

NJ Stark