Product Development Services and FDA Requirements / Proven Reduced Time-to-Market

New Product Development

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

Primary Operating Areas

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