by Methodize | Jan 17, 2017 | Uncategorized
•The guidance finalizes draft recommendations issued by the FDA in 2015. •The guidance includes recommendations for benefit and risk information IDE applicants should submit to the FDA for review and approval. US FDA Investigational Device Exemption (IDE) benefit and...
by Methodize | Jan 4, 2017 | Uncategorized
The US FDA has issued final guidance regarding post-market cybersecurity risk management for medical devices. The final guidance comes about a year after the FDA published draft guidance on managing medical device cybersecurity risks. US FDA final guidance on medical...
by Methodize | Dec 8, 2016 | Uncategorized
The medical device industry is undergoing a period of immense change. In 2016, there has been a new version of the ISO standard for the medical device industry, ISO 13485, as well as two new Regulations, for medical devices (including active implantable medical...
by Methodize | Nov 15, 2016 | Uncategorized
DUE DILIGENCE Methodize provides due diligence auditing services to firms considering a merger with, or acquisition of, a medical device company. Many clients ask us to perform these audits as a means of ensuring the target company will be able to maintain quality...
by Methodize | Sep 26, 2016 | Uncategorized
After the countless hours spent putting together 510(k) submissions, the last thing you want – or expect — is to get a rejection letter from the FDA. However the odds are against you — between January and June of 2015, 69 percent of 510(k) applications were rejected...
by Methodize | Aug 30, 2016 | Uncategorized
US medical device market regulators have clarified their recommendations for when changes to software or firmware should prompt a manufacturer to file a new 510(k) premarket notification for a medical device. New guidance (can be found at...
