What is the current industry thinking on process validation? Our Ask the Experts series posed to the question to Carolyn Guthrie, Director of Regulatory Affairs and Quality Assurance, Kapstone Medical.... Read more »
Four orthopedic additive manufacturing experts answer questions on validation of parts made on different locations on a build plate, process challenge parameters and safety hazards of additive materials.... Read more »
Martin Browning from EduQuest provides insight into the validity of e-signatures from vendors: "Validation must include documentation, or it is not validation. At a minimum, you must establish (note the regulatory meaning of that word) the validity of the e-signatures you want to accept based on you... 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 »
In conjunction, Precision ADM has published a new white paper titled “The Importance of Process Validation in Additive Manufacturing.”... Read more »
An agency representative, and experts from ASTM, DePuy Synthes, and SME, talked additive regulatory issues at OMTEC 2018. Among the insight provided: "Have a good process flow map of all of the steps involved. People tend to focus on the printing portion, but there are a number of steps upstream and... Read more »
Global unique device identification (UDI) and ISO updates are among the regulations and standards that companies must monitor in the coming years.... Read more »
Common problems that OEMs face during packaging validation include determining what validations are actually necessary, understanding all timelines and costs associated with each validation type and re-executing if validation fails. ... Read more »
Mislabeled and misbranded medical devices are one of the top three causes for recalls in the United States. Companies can take several steps to minimize these mistakes — it comes down to being in control.... 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 »
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 »
Design validation is essential to new product development, especially when using multiple suppliers to manufacture your device. Our experts weigh in on how to determine your product is production equivalent.... 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 »
John McCloy offers solutions to reducing the 1% failure rate of medical implants through testing & analysis... 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 »
TSO3 completed sterile efficacy validation for multiple heavy-duty battery-powered orthopaedic instrument sets in a single sterilization cycle.... 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 »
The Agency released the final guidance on considerations for human factors data in premarket submissions, as well as two draft guidances on the topic.... 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 »
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 »
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 »
Novel and non-traditional sterilization processes offer alternatives that enable manufacturers to consider new polymer materials that are not compatible with traditional sterilization methods. Here is a look at the tools and standards for sterilization validation.... Read more »
Verification and validation are commonly confused. John Gagliardi defines the intertwined engineering tools and outlines how they are practiced.... 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 »
If an OEM specifies weak second-tier suppliers, its first-tier suppliers will have fewer resources to devote to its own internal processes. One weak link can prevent the best outcome from occurring. This six-step program helps OEMs ensure that they’re not recommending inferior suppliers anywhe... 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 »
This editorial is the fifth in a series of six articles focused upon the design controls process from a standpoint of design verification and design validation in the orthopaedic medical device marketplace. First, let’s review some pertinent definitions of terms from the 21 CFR, Part 820.30 and IS... Read more »
This is the fourth in a series of articles focused on the design controls process from a standpoint of business acumen as well as meeting customer requirements in the orthopaedic medical device marketplace. Because the design process is controlled and driven by a cross-functional group of individual... Read more »
This is the third in a series of articles focused on the design controls process from a standpoint of business acumen as well as meeting customer requirements in the orthopaedic medical device market. Sometimes called the requirements phase, design inputs are the starting point of understanding the ... Read more »
