by Methodize | Aug 3, 2016 | Uncategorized
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...
by Methodize | Jul 8, 2016 | Uncategorized
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...
by Methodize | Jun 14, 2016 | Uncategorized
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,...
by Methodize | Jun 8, 2016 | Uncategorized
Sorry, I forgot to include the link.. http://www.cfpa.com/CourseDescription/CourseDescription/1607-901L/2724 [risk management] Jack Slovick President Methodize Inc P.O. Box 463 Nevis, MN 56467 763.639.0238 (cell)...
by Methodize | Jun 8, 2016 | Uncategorized
Jack Slovick will be conducting a webinar on the various revision changes to ISO 14971:2012 (per Annex Z,a for medical devices- the deviations), Notified Body interpretations and offering how to revamp your old files up to the new revision [risk management] Jack...
by Methodize | May 25, 2016 | Uncategorized
Cybersecurity for Medical Devices A growing number of medical devices are designed to be networked to facilitate patient care. Networked medical devices, like other networked computer systems, incorporate software that may be vulnerable to cybersecurity threats. FDA...
