Events - Publications - Webinars - Podcasts

 

Date
Topic
Type / Location
Nov. 12 & Nov. 19, 2015
Medical Device Regulatory Affairs 101 -  PDF

Wellesley Community Center
Wellesley, MA

Dec. 9, 2014
Future Medical Applications in 3D Printing: Clinical Benefits,
Regulatory Issues and Manufacturing Challenges
 -  PDF
Webinar
Nov. 21, 2014
Successful 510(k) Clearance: Strategies for Winning Substantial Equivalency Arguments Massmedic  -  PDF
Mass Medic, Waltham, MA
Nov. 16, 2014
Future Medical Applications in 3D Printing: Clinical Benefits, Regulatory Issues and Manufacturing Challenges  -  PDF
Functional Analysis and Screening Technologies Congress
Nov. 13, 2014
How To Take Advantage Of The Companion Diagnostics Opportunity  -  PDF
Webinar
Nov. 6 2014
Connecting Device Engineering to Your Bench Top Test and Clinical Trials, Reducing Cost and Time to Market  -  PDF
Webinar
Nov. 5, 2014
The Premarket Notification/510k Submission: Using Substantial Equivalence to Your Advantage!  -  PDF
Webinar
Oct. 30, 2014
The Premarket Notification a.k.a. 510k: Using Substantial Equivalence to Your Advantage!  -  PDF
MDM/Minneapolis
Oct. 30, 2014
Best Practices in Responding to Complaints, Recalls and Warning Letters - PDF
MDM/Minneapolis
Oct. 29, 2014
Recent Advances in Bioresorbable Polymers  -  PDF
MDM/Minneapolis
Oct. 29, 2014
Recent Advances in Bioresorbable Biomaterials  -  PDF
MDM/Minneapolis
Oct. 28, 2014
Combination Products: A Comprehensive Overview of Premarket Opportunities and Postmarket Challenges  -  PDF
DIA, one-day tutorial
Oct. 22, 2014
How to Spark a Revolution in Medical Plastics
QMed
Oct. 19, 2014
Biomedical nanotechnology: The smaller the thing, the bigger the challenge!  -  PDF
Column-Article
HealthCare Packaging
Oct. 16, 2014
The Premarket Notification/510k Submission: Using Substantial
Equivalence to your Advantage!
 -  PDF
Webinar
Oct. 2, 2014
Stability Challenges of Combination Products - How do we Combine Drugs, Biologics, Medical Devices and More?
Cold Chain Forum, Boston
Sept. 23, 2014
Future Medical Applications in 3D Printing: Clinical Benefits,
Regulatory Issues and Manufacturing Challenges
 -  PDF
Webinar
Sept. 18, 2014
Medical Device Regulatory Affairs 101: Regulatory Affairs For Non-Regulatory Personnel  -  PDF
Webinar
Sept. 18, 2014
Medical Device Regulatory Affairs 101: Regulatory Affairs For Non-Regulatory Personnel  -  PDF
Webinar

Sept. 12, 2014

510(k) Substantial Equivalence In Plain English - Part 1  -  PDF [Part 2 will be out in two weeks.]

Listen to the podcast Simplifying Substantial Equivalence In FDA Premarket Notifications

Column-ArticleMed Device Online
Sept. 10, 2014
Combination Products: Clinical benefits, regulatory issues & manufacturing challenges
Omics Group
Sept. 10, 2014
Biomedical Nanotechnology: The smaller the thing, the bigger the challenge!
Omics Group
Aug. 25, 2014
Biomedical nanotechnology: The smaller the thing, the bigger the challenge! (HealthCare Packaging)   PDF
Column-Article
Aug. 23, 2014
Commercializing Disruptive Medical Technologies in an Evolutionary World   - PDF   watch highlights
Healthtech Venture Network
Aug. 15, 2014
Everything You Know about Materials Is Wrong (Qmed)  -  PDF
Column-Article
Aug. 8, 2014
Panel discusses legal, ethical concerns of 3D printing (American Bar Association Annual Meeting)  -  PDF
Column-Article
Aug. 2014
Is Your Boring Regulatory Strategy Costing You Business  -  PDF
Column-ArticleMed Device Online
Jul. 23, 2014
Communication With FDA: What Do We Say And How Do We Say It?  -  PDF
Webinar
Jul. 15, 2014
Understand the Medical Device Classification System: Best Practices for Selecting the Best Fit  -  PDF
Webinar
Jul. 2, 2014
Take Control Of Your Medical Device's FDA Classification (MED Device Online)  -  PDF
Column-Article
May 2, 2014
3 Tips To Vastly Improve Your FDA Communication Strategy    (MDDI)  -  PDF
Column-Article
Feb. 24, 2014
De Novo Path to Device Approvals: Tips for Speedy and Successful Outcomes  -  PDF
Webinar
Feb. 11, 2014
How to Sharpen Your Regulatory Sword   (MDDI)  -  PDF
Column-Article
Guerilla Regulatory Strategy (MED Device Online Regular Contributor)
Column-ArticleMed Device Online

 

 

 

Unable to attend in person?  Podcasts and handouts are available for many presentations.  Contact us to gain access.