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Ten Tips for A Successful Use of Total Product Life Cycle (TPLC) Reports

The FDA, as part of the transparency initiative, has developed a Total Product..

Ten Tips for Successful Integration of Risk ...

Even though Risk Management and Usability Engineering are clearly two separate..

510(k) Submissions-Ten Tips for a Successful ...

The process of submitting a 510(k), demonstrating that your device is..

Successful Regulatory Strategy-Ten Tips

Having a documented regulatory strategy developed early during a new product’s..

CAPA - Best Practice Sharing

Healthy CAPAs = Competitive Advantage

Implementing a Successful Recall Process - Ten ...

In the medical device arena, recalls are a fact of life and competitors love to..

Warning Letters - Ten Tips

Each year, the FDA issues hundreds of warning letters to medical device..

Q-Sub, FDA, Guidance Document, Pre-Sub, PMA, 510(k), Pre-Submission

Pre-Submission Program – Final Guidance

On February 18, the FDA issued the final guidance document for the..

Affordable Breakthrough Innovations

Innovative ideas for medical devices are often costly for manufacturers to make..

guidance documents, 23andMe, FDA, Custom Device Exemptions

Guidance Documents for 2014

In an effort to help get safe and effective medical devices to market more..

FDA, medical device, PMA

Pediatric Subpopulations – Final Rule

On Friday, January 10, 2014 the FDA issued a final rule, which amends the..

FDA, 510(k) review, 510(k), CDRH

510(k) Pop Quiz!

How well do you know the logistics of the 510(k) process? Today’s blog is..