Product Development Services and FDA Requirements
Proven Reduced Time-to-Market
Getting new product into market quickly and effectively is the key to success. Developing product consistent with FDA requirements while not slowing the R&D effort is a tricky business; if the system is designed properly, you can have both.
510(k) Submission:
While FDA’s clearance process has become unpredictable, it's become a significant barrier to new product introductions in the US. We’ve discovered ideas that make the process go smoother for quicker results.
- 510(k) strategy development
- Risk analysis (design, process and user)
- Usability study and validation
- Labeling Compliance
- 510(k) Writing
- 510(k) follow-up with FDA as required
Technology Transfer
- Domestic
- International (including Asia)
Project Management
Design Control: QSR Compliance
- Evaluate company’s practices
- Streamline design control process
- Must be easy to follow and implement
- System helps the development process
- Develop and implement
- Validate and train
Material Qualification
- Biocompatibility Test Strategies
- Laboratory Selection
Packaging
- Package Design and Qualification
- Prototype Testing
- Packaging Equipment Selection
- Packaging process Development
- Sterile package sealing
- Packaging process Validation
Sterilization
- Ethylene Oxide
- Steam/autoclave
- Gamma
- E-Beam
- Bioburden Assessment
- Sterilization Process Development
- Sterilization process validation
- Pyrogen Control
Risk Management
- Risk Analysis
- HACCP
- FMEA
- Fault Tree Analysis
- ISO 14971
- Design, process user risk
- Risk mitigation
- Usability study and validation
Process Development:
- Process design
- Process controls
- Documentation
- Training
Inspection Strategies and monitoring:
- In-process vs. finished
- Sampling plans
- Action limits
- Particle monitoring
Material qualification and supply-chain:
- Inventory control
- Purchasing specification and controls
- Approved vendor list
- Supplier qualification
