Premarket Notification 510(k) Submission Support
Perfectus Biomed support companies with their data generation portfolio in order to support their 510(k) submission.
The FDA require 510(k) premarket submissions for new devices that are not subject to Post Market Approval (PMA). The submission demonstrates that a device to be marketed is at least as safe and effective as a legally marketed device (21 CFR 807.92(a)(3)). Submitters must compare their device to one or more similar legally marketed devices.
Requirement of 510(K) submissions:
- When commercial distribution of a new device is occurring for the first time.
- When there is a change/modification to an existing legally marketed device that may affect its safety or effectiveness.
If you would like more information or you wish to discuss this further, please contact us.
Our library of test organism includes…
Choose from our library of test organism including standard reference strains, clinical isolates and environmental isolates.
Single or mixed species assays containing:
Enterococcus faecium (VRE)
Staphylococcus aureus (MRSA and MSSA)
WHO Priority organisms.
Other- please ask.
Wound Care Test Methods
- Standard Update – BS EN 13704:2018 Chemical Disinfectants
- Perfectus Biomed successfully maintain ISO 9001:2015 certification
- Sci-Tech Daresbury post article on Perfectus Biomed’s growth
- Perfectus Biomed attending CBE’s 2018 Biofilm Science & Technology meeting in Montana
- The FDA’s 510(k) Submission Process; Common Reasons for Receiving a Refuse-to-Accept (RTA) Decision
- Perfectus Biomed, BSN Medical and the University of Huddersfield collaborate on Innovate UK project!
- Perfectus Biomed are exhibiting at WCICT 2018
- Perfectus Biomed relocate to brand new office and laboratory!
- Perfectus Biomed are exhibiting at Biofilms 8, 2018
- Perfectus Biomed will be exhibiting at the Dental Technology Showcase 2018