Orthopedic Stakeholders Talk Coating Standards
Orthopedic and coating manufacturers are leading the discussions with ASTM, ISO and FDA to set standards and guidance for current...
Mar 06 2019,
Regulations
Device Design Should Favor Scientific Approaches Over Check-the-Box Mentality
When it comes to solving complex problems, such as the orthopedic device design control process, the incompetency and laziness from...
Mar 05 2019,
Orthopaedic Companies Collaborate with NESTcc on Real-World Evidence Considerations
The National Evaluation System for health Technology Coordinating Center launched its first round of Real-World Evidence Test-Cases, which include...
Jan 21 2019,
FDA Works to Modernize 510(k) Process
This more modern 510(k) pathway is to be used for clearance of low- to moderate-risk devices. It has a focus...
Jan 18 2019,
FDA Priorities: People, Simplicity and a Risk-Based Approach to Speed Time to Market
By utilizing a more straightforward methodology, FDA can free up and better use resources to focus on high-risk areas that...
Dec 10 2018,
Can You Trust E-Signatures From Your Software Package Vendor?
Martin Browning from EduQuest provides insight into the validity of e-signatures from vendors: "Validation must include documentation, or it is...
Dec 04 2018,
FDA Takes Several Steps to Strengthen Medical Device Cybersecurity Program
In order to stay current with the evolving technological landscape and increased insight into cyber threats, FDA recently addressed cybersecurity,...
Dec 04 2018,
Crucial Validation Considerations for Instrument Cases and Trays
Common challenges device company engineers face during validation of delivery systems include case/tray longevity, robustness of design, maintaining integrity of...
Oct 08 2018,
Sterilization Expert Stresses Importance of Biocompatibility, Endotoxins, Planning
Recent updates to standards and regulatory guidance have made sterilization processes more complex....
Oct 05 2018,
How to Respond to FDA Inspection Observations, Even Those You Dispute
Martin Browning from EduQuest provides insight on responding to Form 483 observations: "It’s critical to show FDA that you are...
Oct 04 2018,
25 Considerations for Companies Seeking Clarity in Design Controls
OEMs must be aware of and comply with design control requirements included in 21 CFR, Part 820. Unsafe, ineffective devices...
Sep 24 2018,
How the European Union’s MDR Will Impact Your Company’s Supply Chain
OEMs must engage partners in conversations about the information needed from each party for Medical Device Regulation in order to...
Aug 02 2018,
FDA Responds to Additive Questions on 510(k) Submissions, Reusing Powder, Testing
An agency representative, and experts from ASTM, DePuy Synthes, and SME, talked additive regulatory issues at OMTEC 2018. Among the...
Aug 01 2018,
Think Different About Management Reviews
When done correctly–with preparation and an energized approach–these reviews can complement strategic planning and measure the effectiveness of your QMS...
Jun 28 2018,
Making a Device Design Change? Document These Critical Steps
No matter where you are in the design process and no matter your internal procedures, control and documentation of design...
Jun 28 2018,