The implementation provides a validated QMS solution to accommodate increased regulatory requirements. ... Read more »
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 »
Incorporate sound quality management systems into the production of new products and processes so that regulations become guiding principles for continued growth as opposed to hurdles that companies fear.... Read more »
By utilizing a more straightforward methodology, FDA can free up and better use resources to focus on high-risk areas that have the biggest impact. "Simplicity requires that FDA remain limber," writes John Gagliardi. "For industry to be innovative, the federal government must be innovative as well."... Read more »
When done correctly—with preparation and an energized approach—these reviews can complement strategic planning and measure the effectiveness of your QMS in relation to your business model.... Read more »
ISO 13485:2016 has a greater emphasis on risk management and risk-based decision making.... Read more »
While device manufacturers were slow to adopt the program in its pilot days, the initiative has gained traction since FDA named it an official program earlier in 2017. ... Read more »
Medical device companies have until March 1, 2019 to update their quality management systems to the ISO 13485:2016 standard. The simultaneous introduction of the Medical Device Single Audit Program and transitions to ISO 9001:2015 will leave manufacturers busy and certification bodies slammed. There... 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 »
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 »
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 »
ISO 13485 Certification is the quickest pathway to achieving CE Marking approval. Manufacturers should follow these sequential steps as a roadmap to certification.... Read more »
Auditors are human. The question is: What should you do when they're wrong?... 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 »
RABQSA International (RABQSA) and BSI Group America have co-developed an innovative Medical Devices training curriculum, created for individuals wishing either to become trained to audit to the Medical Devices Standard (ISO 13485) or simply to understand the requirements of a medical devices quality... Read more »
