Experts Offer Strategies for Clinical Trial Execution and Outsourcing
Experts share their insights on best practices and strategies for conducting clinical trials inside and outside of the U.S., as...
Sep 09 2014,
Regulations
FDA Clarifies Substantial Equivalence Requirements for 510(k) Submissions
FDA attempts to clarify substantial equivalence requirements in its latest 510(k) guidance. What do these changes mean for your next...
Sep 09 2014,
Choosing Materials in a Shifting Global Regulatory Environment
Orthopaedic device manufacturers face increasing pressures related to the safety of raw materials used in implants and instruments. Consider these...
Aug 05 2014,
Effective Tools for Patent Searches
Management has given the go-ahead to design a new device. As an engineer, you’ll now conduct a patent search to...
Jul 09 2014,
The Starting Line: Turning the Corner with a Device Concept
New orthopaedic device concepts from surgeon entrepreneurs and novice inventors often hit snags when facing the reality of the regulated...
Jul 08 2014,
Protecting Inventions and Brands: IP Due Diligence in the Product Development Process
The importance of IP due diligence is often overlooked when bringing an orthopaedic device through each of the eight stages...
Jun 03 2014,
UDI Implementation: What are Your Next Steps?
Creating a playbook or strategic plan is an absolutely necessary step of UDI implementation. The major components of your plan...
Jun 03 2014,
Sunshine Act and Beyond: Improving Compliance
A crucial component of the new regulatory environment is adherence to the Physician Payment Sunshine Act, requiring manufacturers to report...
May 07 2014,
Design Controls: A 17-Year Learning Curve
Developing a new device and introducing it into production are very complex tasks. Thorough planning, process control and design controls...
May 07 2014,
FDA Expectations: Overcoming Supply Chain Weaknesses
FDA expectations of supplier management will continue to evolve as pressures are applied to the agency, device recalls are issued...
Apr 24 2014,
Sterilization: How to Validate Novel and Non-Traditional Processes
Novel and non-traditional sterilization processes offer alternatives that enable manufacturers to consider new polymer materials that are not compatible with...
Apr 11 2014,
How Far is “Possible” for Risk Management?
A controversial interpretation of the medical device CE Marking requires risk reduction without room for economic consideration. This approach conflicts...
Apr 09 2014,
Five Steps to Regulatory Strategy Development
Regulatory requirements continue to evolve and become increasingly complex. A solid strategy and execution can maximize opportunity to achieve regulatory...
Mar 11 2014,
Synergetic Dissimilarity: Design Validation/Verification and Process Validation
Verification and validation are commonly confused. John Gagliardi defines the intertwined engineering tools and outlines how they are practiced....
Mar 11 2014,
Five Ways to Prevent Complaint Handling Pitfalls
Learn how to avoid receiving 483s from other's previous mistakes. This article analyzes the five most common 483s related to...
Mar 05 2014,