Basic Anatomy of a Design Dossier
This article summarizes key elements required for technical documentation of medical devices provided by manufacturers in order to demonstrate conformity...
Mar 31 2011,
Competitive Landscape
Corrective and Preventive Action: What Does FDA Look For During Inspection?
The orthopaedic industry faces strong pressure from regulatory bodies as well as from the industry to maintain the quality of...
Mar 31 2011,
A New Inspection Paradigm
The device industry has been abuzz with discussion of non-contact inspection methods like White Light Scanning and Computer Aided Inspection....
Mar 31 2011,
Beware of the Falsely Patent Marking Boogey Man
Within the past 18 months, a cottage industry has started to emerge. This disruptive industry exists to sue companies for...
Mar 31 2011,
Clinical Strategy Review for CE Marking
The Notified Body British Standards Institution (BSI) has launched the Clinical Strategy Review for manufacturers applying for CE marking. (See...
Dec 31 2010,
Review of Study Results: FDA Impact on U.S. Medical Technology Innovation
FDA Impact on U.S. Medical Technology Innovation, a study released in November 2010, was undertaken to provide a view of...
Dec 31 2010,
Change Management and S&OP: Part II
Even though the logic of Executive S&OP is simple, implementing it is not. Implementing it requires people to make changes....
Dec 31 2010,
Comparative Effectiveness: From Theory to Practice
What differentiates CER from traditional medical research is that CER is demand driven....
Dec 31 2010,
You May Own a Copyright and Not Know It!
Copyrights are rampant in the world of orthopaedics and are, most of the time, ignored or forgotten. Copyrights can be...
Dec 31 2010,
Design Controls: Design Transfer, Changes and the Design History File
Introduction and Review As you may recall from the first and second articles in this series, each manufacturer of orthopaedic medical...
Dec 31 2010,
The Benefits of Capturing Product Data Are High – The Costs of Doing So Don’t Have to Be
Choosing the right data collection partner and process can help device companies differentiate themselves in the minds of surgeons....
Dec 31 2010,
2010 Orthopaedic Year in Review, Positive Signs for 2011
FDA regulatory changes, reimbursement and healthcare reform have created significant uncertainty regarding the ability to get new products approved and...
Dec 31 2010,
Notified Body Requirements for Clinical Literature Evaluation
The most recent revisions to the European medical devices directive have underlined the importance of clinical data in demonstrating compliance...
Dec 31 2010,
MDD Regulations: What I Wish I Had Known
Having worked in medical device research and development for over 20 years, I have contributed to many regulatory submissions for...
Sep 30 2010,
Change Management and S&OP
Some years ago, I spoke with a gentleman from Ford Motor Company’s Lean Supplier Institute whose job it was to...
Sep 30 2010,