Tania Shammo, formerly of In'Tech subsidiary Bradshaw Medical, has been appointed Director of Global Regulatory Affairs & Quality Assurance. ... Read more »
Assure provides traceability of machine health, part integrity and build reporting. Stratasys Direct Manufacturing is the first user of Assure. ... Read more »
Regulatory and quality orthopedic professionals offer advice on ways that they would manage the gray areas of complaint reporting and clinical evaluation writing.... 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 »
While many opportunities arise for companies that implement additive manufacturing, headwinds are also faced. Experts from K2M, 4WEB Medical, LimaCorporate and Ampower provide insight into design, quality, lead time and other critical AM issues. ... Read more »
In this installment, supply chain experts from Autocam Medical, MicroPort Orthopedics, Orchid Orthopedic Solutions and Zimmer Biomet discuss customer differentiation, building partnerships, regulatory challenges and continuous improvement efforts. ... Read more »
The OMTEC® 2018 opening Keynote Panel offered perspective on hospital actions and priorities while addressing critical industry topics including pressure from public and private payors, bundled payments, value analysis committees and outpatient surgeries. ... Read more »
Thorough process development, optimization and control using appropriate statistical methods and tools is recommended to show that processes are stable and capable.... 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 »
When an OEM specifies weak second-tier suppliers, its first-tier suppliers 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 recommending top suppliers throughout the chain.... Read more »
Regulatory bodies do not see supplier quality agreements as a new requirement. They also expect medical device manufacturers to require suppliers to conduct remediation where required and within documented timelines. It is appropriate to use a risk management approach to prioritize required focal po... 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 »
During his OMTEC presentation, Joe Mazzeo pinpointed the principles necessary to build a culture of inherent quality, stressing strong leadership and cultural tenets to drive lean manufacturing and create value.... Read more »
On February 5, 2015, a second draft of ISO 13485 was released to the world for comment. How will new quality system requirements in the latest version of ISO 13485 affect you?... Read more »
A CDRH quality system data report offers insight into common observations from 2013. Familiarize yourself with these trends and action items to avoid quality issues.... 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 »
UPDATE: Mr. Packard's blog has moved to Medical Device Academy. Also, find his BONEZONE articles by clicking on the author tab on the homepage.
Quality Control can be stale. Reading about it can be even duller. Rob Packard wants to change that by bringing the topic to life with his blog, QC i... 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 »
InVivoLink Introduces OrthoPod, a Tablet-based Implant Registry Application;
Emergo Group Medical Device Blog for QA/RA Professionals;
IMARC Research Blog... 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 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 »
