Preparing for Unannounced Audits
The long awaited unannounced audits for manufacturers of CE marked medical devices were started last year by almost all Notified Bodies. So how can manufacturers prepare for the changes?
Warning Letters Show Common QSR Problems
A quick review of the violations in 2014 Warning Letters shows that FDA inspectors are scrutinizing multiple areas of operation, from production to receipt of supplies to management responsibilities to CAPA systems.
Regulatory Innovation Should Adapt to New Health Economy
Forty-three percent of pharma and life sciences executives now support FDA evaluating drugs and devices based on both clinical and economic effectiveness.
Why is Biocompatibility Testing of Medical Devices Critical?
Even if a material that makes up the medical device has been tested for biocompatibility, processes such as manufacturing, packaging, aging, and sterilization may have adverse effects on the material’s composition and how it reacts in different environments. Because of these potential changes, biocompatibility is an important test protocol that must be completed for every medical device end product prior to receiving global regulatory approvals. An upcoming series of seminars, organized by UL, will discu…
How is Industry Dealing with Tax – Survey Results Tell Story
The U.S. Medical Device Excise Tax continues to draw scorn from industry advocates as a jobs killer. However, new data from a survey tells a different story about how executives are compensating for costs of the tax, and that story varies considerably by size of company.
FDA’s Single Audit Program Invites Participants
The MDSAP pilot has reached a major milestone with manufacturers around the globe interested in marketing medical devices in Australia, Brazil, Canada, and the U.S. invited to participate in the program.
Not having adequate resources, resulting in no audits being performed, is never going to be a viable excuse in the eyes of an FDA investigator. Quality Audits are mandated by the QSR and compliance with Section 820.22 is not optional.
All device establishments may suffer from the occasional “solecism” or inaccuracies associated with managing a dynamic quality management system, however, when nine Form 483 observations are documented in an agency warning letter, the QA and RA folks are more than likely fast asleep at the proverbial wheel.
The Key to Successfully Selling Medical Devices in China and Japan – Good Distributors
One of the best ways for small and mid sized Western device firms to take advantage of these growing markets is to conclude agreements with reputable, trustworthy, and well connected medical device distributors located there.
Making the News for All the Wrong Reasons
With an aging population, technological innovations and more and more people needing medical devices for a sustained quality of life, the risk of long-term harm or damages increases when devices are not manufactured, imported or used properly.
