CHEMICAL, BIOCHEMICAL, QA REGULATORY
AND FDA EXPERTISE
Breakwood has over 40 years of chemical, biochemical and medical device experience. We are proud to assist our customers and share our expertise invitro diagnostic solutions, clinical chemistry analysis and clinical chemistry instruments. With our extensive background, we can provide FDA consulting on approval for medical devices.
If you don’t see the specific capability, you need listed below, please contact us for a no obligation consultation.
- Chemical, enzymatic, ELISA
- Absorbance, fluorescence, time-resolved fluorescence detection
- Chromatography
- Membrane-capture assays
- HPLC, GC, Mass spec
- X-ray fluorescence, NMR
- FTIR
- Assay automation
- Assay calibration
- Assay troubleshooting
- Assays using blood spot samples
- External and internal standards
- Assay evaluation / validation studies
- Precision
- Method comparison
- Linearity
- Detection limit (LoB, LoD, LoQ)
- Interference testing
- Stability (real-time, accelerated aging, sample, calibrator and control, on-board, reconstituted)
- Carryover
- Sample matrix comparison
- Normal ranges
- Temperature impact
- OEM procurements / Vendor audits
- Arranging contract manufacturing of diagnostic kits and controls
- Formulation and stabilization of kit components
- Calibrators/controls/standards
- Blood processing
- Lyophilization
- Kit manufacturing and quality control
- Diabetes monitoring and testing
- Vascular disease risk factor testing
- Newborn screening/inborn errors of metabolism
- Hemoglobinopathies
- Fetal lung maturity testing
- Autoimmune disease testing
- Instrumental Analysis (standard and special chemistries)
- Assay Automation
- Immunoassays
- In vivo sensors
- Autoanalyzers
- Ion selective electrode testing
- Animal testing
- Viscosity testing
- Ionic strength and pH testing and control
- Molecular and equivalent determinations
- Sample preparation and cleanup
- Solid phase extraction
- Desalting / buffer exchange / dialysis
- Affinity chromatography
- Organic synthesis
- Ligand attachment
- Liposomes
- Silicone polymerizations and coating
- Emulsion polymerization
- Lamination, adhesives and bond strength testing
- Manufacturing method analysis/improvement
- Equipment validation
- Process validation
- Test method validation
- Cleaning validation, testing and qualifications
- Cleanroom validation
- Design controls
- Product verification/validation studies
- Root cause analysis
- Corrective and preventative action (CAPA) systems, analysis and resolution
- Nonconformance reports (NCRs)
- Design of quality control specifications and quality systems
- Internal audits
- Medical device reporting
- Raw material tolerances/qualifications
- Training of production and quality control personnel
- 510(k) Applications – kits, controls, instruments, software
- Providing data for other regulatory approvals
- Clinical trial management
- Writing package inserts and labeling
- Addressing FDA questions and concerns
Past FDA registrations:
- 133 successful device approvals
- (application to approval)
- Obtained the first ever de novo approval (no predicate device) of an in vitro diagnostic kit