It is critical that companies in the medical device space have comprehensive, well-written, and descriptive procedures not only for documentation, but for assessing the impact of any and all changes, no matter how minor.
The guidance looks at what constitutes a manufacturing site change, when a manufacturer should submit a PMA supplement, what documentation should be submitted to the FDA with a site change supplement, and more.
This article examines a report issued by the Office of the Inspector General of the Department of Health and Human Services, resultant of an audit of the FDA’s internal processes to ensure cybersecurity in the postmarket phase of medical devices – as well as the FDA’s disagreements with the findings and what this means for manufacturers going forward.
Harmonized standards need to be reviewed and revised to reflect requirement changes under the MDR and IVDR. The creation of Common Specifications, as well as changes to ISO 14971, further complicate the transition for med device manufacturers.
The “messy, getting started” period in pre-product development can make many development teams and life science organizations uncomfortable – until you recognize “fuzzy” as less of a warning, and more of an invitation.
To fully realize the potential of bioelectronic medicine, medical device developers will need to find ways to move beyond “set and forget” biostimulation devices to closed-loop systems that can provide more responsive and personalized treatments.
The FDA guidance Medical Device Accessories – Describing Accessories and Classification Pathways, clarifies much of the confusion regarding accessory classifications, making now a good time to conduct a gap analysis to identify a thorough list of your current and future accessories, and to determine the guidance’s applicability to each.
The EU’s General Data Protection Regulation (GDPR) will go into full effect on May 25, 2018 — as will penalties for non-compliance. While most of the GDPR affects the back end of medical device data handling, the Cloud, Databases, and transportation of data, some of the GDPR affects software on medical devices themselves: