How should you prepare for FDA 510(k) submissions in 2020? Start with a thorough understanding of the testing and verification and validation work you need to complete prior to submission.... Read more »
CLS seeks to expand its overseas customer base, particularly with U.K. firms in a post-Brexit environment. ... Read more »
Orthopedic device companies should proactively ask FDA and other regulatory bodies about important testing requirements and changes to regulations and standards.... Read more »
EndoLab's facilities perform tests for hip, knee, extremity and spinal implants. ... Read more »
The move doubles AccelLAB's original histology lab space. ... Read more »
Common challenges device company engineers face during validation of delivery systems include case/tray longevity, robustness of design, maintaining integrity of ID markings and establishment of worst-case testing parameters. ... Read more »
The LTM line of testing systems features an electro-dynamic drive based on linear motor technology.... Read more »
This acquisition expands the U.S.-based analytical testing capabilities of Nelson Laboratories.... Read more »
Service capacity is doubling at the company’s Itasca, Illinois lab.... Read more »
By recording actual results, instead of pass/fail, you can better investigate failures that may occur in production/post-production. This approach also helps to verify the specification you originally developed is appropriate and effective for your products.... Read more »
FDA published its guidance on additive manufacturing technical considerations, outlining the Agency’s long-awaited position on use of the technology for medical devices.... Read more »
The combined company – called JTL America – will offer expanded mechanical and analytical testing capabilities for the orthopaedic and automotive industries.... Read more »
Computational modeling and simulation (CM&S) can revolutionize medical devices by accelerating innovation and providing evidence of long-term safety.... Read more »
Consider use of the acceptance sampling approach or the six sigma acceptable error approach to determine a sample size using statistics. ... Read more »
The elements are derived from the biological, mechanical or clinical performance requirements of the device and regulatory requirements for performance and safety.... Read more »
CarTech Puris 5+ exceeds the standard Ti 6Al-4V Grade 5 strength levels by nearly 18%.... Read more »
EduQuest, a global team of FDA compliance experts, answers industry’s pressing questions. In this round, Denise Dion, Vice President of Regulatory & Quality Services for EduQuest, corrects a common misconception.... Read more »
A new field emissions SEM produces high-resolution images above 120,000 times magnification, allowing more in-depth insights than conventional devices. ... Read more »
Testing is, of course, a critical component to product development. To better understand how it can be proactively employed to help ensure product quality and longevity, we reached out to John McCloy, Founder & President of Engineered Assurance and author of the article on the industry’s 1% fa... Read more »
If your company struggles with deciding when to elevate a complaint to the level of a CAPA, how do we differentiate between complaints, non-conformances and CAPAs? Our experts respond.... Read more »
If you’ve characterized a material change to your medical device and confirmed no impact to any of your design inputs or outputs, do you have to formally perform verification and validation? Our experts respond.... Read more »
U.S.-based MDT's services include Orthopaedic Device Fatigue Testing, Corrosion Testing and Particulate Counting and Analysis. ... Read more »
John McCloy offers solutions to reducing the 1% failure rate of medical implants through testing & analysis... Read more »
Commercialization of Zwick’s LTM 5 and LTM 10 stemmed from direct customer feedback.... Read more »
The contract test lab now offers spine and knee wear testing.... Read more »
This software update supports precise, rapid digital inspection for quality management and metrology workflows.... Read more »
The new center supports the ability to verify the identity and integrity of the precision bar products, mitigating material risk.... Read more »
All medical devices must be tested. However, the varied aspects of device testing can be unfamiliar ground, and standards are often vague guidelines, open to interpretation.... Read more »
Advances in the development of prosthetic joints and materials have led to a need for more effective testing solutions to drive the development of new and improved implants.... Read more »
Vagueness in standard methods and regulatory guidance surrounding instrument testing and validation has left OEMs questioning what best practices to apply to their devices.... Read more »
Lucideon will host a webinar titled Cleaning Validation of Reusable Medical Devices on June 9 at 10 a.m. (EST).
Medical devices need to be cleaned thoroughly and effectively to ensure their safety in use. Reusable devices (such as surgical tools) require reprocessing (cleaning and disinfection/ster... Read more »
Additive manufacturing and the domination of digital communication and information transfer pose new concerns for manufacturers.... Read more »
Prudent manufacturers already know that the deployment of human factors and usability engineering go beyond meeting regulatory requirements. Manufacturers can leverage their programs to cut costs, mitigate risks and understand how they stack up to competition in the market.... Read more »
For orthopaedic device manufacturers, new concerns are cropping up during the device testing process due to regulatory changes and the emergence of new materials and technologies in the industry.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
