BIOCOMPATIBILITY, ANTI-BIOFILM TESTING,
FDA 510(K), MHRA & EU MDR REGULATORY SUBMISSIONS
GLP COMPLIANT ORTHOPAEDIC DEVICE TESTING
FDA 510(k) /PMA regulatory pathways support. Perfectus Biomed can accelerate Pre-IND applications and highlight competitive advantages. GLP compliant.
The number of patients with orthopaedic device-related infection (ODRI) is on the rise due to an increase in orthopaedic implants. Infections relating to orthopaedic implants result in numerous problems for the healthcare industry, such as implant replacement and patient pain and discomfort, therefore increasing healthcare costs. Antimicrobial treatment of orthopaedic devices is crucial, and so improving the antimicrobial nature of medical implants will therefore improve patient well-being while reducing healthcare costs.
Perfectus Biomed can help support your research and development into microbial infection control of orthopaedic implants, from proof of concept to regulatory orthopaedic device testing.
Standard and customized test methods include biocompatibility testing, anti-biofilm testing, coating efficacy and endotoxin detection tests. GLP-compliant testing is also available.
Please contact us to discuss further.
We are experts in:
- Biocompatibility testing
- Coculture assays
- Cell integration assays
- Cytotoxicity testing
- Endotoxin testing
- Topography testing
- Implantable orthopaedic device testing
- Planktonic bacteria
We have experience with:
- Established biofilms
- Bacterial attachment
- Fungal/yeast cultures
- Anaerobic cultures
- Implantable medical devices
- Antimicrobial coatings
- Orthopaedic implants
- Bone cements