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
- Perfectus Biomed are exhibiting at the Symposium on Advanced Wound Care (SAWC) Spring 2018 conference
- Perfectus Biomed are attending Pharmig’s PCP Conference
- World Health Organisation (WHO) released data to show high levels of antibiotic resistance worldwide
- Perfectus Biomed – Microbiology Testing in the USA, Europe, Australia and South Africa
- Perfectus Biomed win Entrepreneur of the Year and the Award for Innovation at the High Sheriff Awards!
- Perfectus Biomed are finalists in the High Sheriff of Cheshire Enterprise Awards
- Perfectus Biomed co-publish paper in the Journal of Wound Care
- Perfectus Biomed Exhibiting at Cleaning Products Europe 2018
- Perfectus Biomed Breakout!
- Journal of Wound Care Award Winners 2018