from the FDA, the EU, Health Canada, and more
Regulatory Updates
Final FDA guidance explains how the agency evaluates benefit and risk issues in Investigational Device Exemptions (IDE) for medical devices that require clinical trials in order to be registered.
•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...
Final US FDA Guidance on Post-market Cybersecurity Risk Management
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 The final guidance comes about a year after the FDA published draft guidance on managing medical device cybersecurity risks.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...
ISO 13485:3026
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...
Due Diligence and QMS assistance
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...
Reasons Your 510(k) Submission Will Be Rejected (And How To Avoid Them)
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...
When Medical Device Software Changes Warrant a new FDA 510k
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...
UDI updates from FDA
New guidance from the US Food and Drug Administration lays out key components of Unique Device Identifier (UDI) form and content that medical device manufacturers should incorporate into their compliance efforts. In the guidance document (provided by the following...
MEDDEV 2.7/1 Rev 4
Following the release of MEDDEV 2.7/1 Rev 4 with updated guidance on clinical evaluations in Europe, Methodize takes a closer look into some of the new version’s recommendations and their impacts on medical device manufacturers. Latest revision In June 2016 Revision 4...
New updates on MDR and IVDR specific to their progress
New updates on MDR and IVDR specific to their progress Methodize has some new developments to share in regards to the progress of the draft MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation) documents, as well as a new revision of the MEDDEV...
UDI REQUIREMENTS IN THE EUInline image
As the United States expands the scope of the FDA Unique Device Identification (UDI) system to include additional medical devices classes, other countries are moving forward to create similar UDI systems to better identify medical devices from the manufacturer,...