Our Services

Our Services 2018-06-02T15:00:18+00:00

Design and Development Consulting

Need help with complying with FDA and EU design control requirements?

  • Assistance with understanding the complexities of the Design Control process, and ensuring compliance with FDA and European requirements: Design Inputs, Design Outputs, Design Verification, Design Validation, etc.

  • Assistance with drafting key design control documents: Design and Development Plan, Quality Plan, Risk Analysis, etc.

In Vitro and In Vivo Testing

  • We can assist in the development of in vitro tests necessary to complete Design Verification requirements

  • We will identify test labs and develop protocols for animal testing

  • We will ensure compliance with ISO 10993 requirements for demonstrating biocompatibility

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Manufacturing Consultancy

  • Evaluate manufacturing process options and identify suppliers

  • Determine cost of goods for selected process flow, and identify opportunities for reducing cost

  • Develop IOQ and product qualifications protocols for new equipment and processes

  • Ensure compliance with FDA current good manufacturing practices (cGMP) requirements

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Intellectual Property

  • Conduct prior art searches to identify and address competitive IP

  • Evaluate prior art to ensure “right to practice”

  • Draft claims and embodiments to save time and money in the application preparation process

  • Craft responses to overcome examiner rejections

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Need Assistance with Regulatory Compliance?

Ensure compliance to all U.S. and EU Quality System requirements:

  • 21CFR820 U.S. quality system regulations

  • 21CFR210, 211 U.S. cGMP manufacturing regulations

  • ISO 13485 – European quality management system requirements

  • ISO 14971 – Quality risk management requirements

  • ICH Q1A(R2) – Product stability testing requirements

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Market Modeling

  • Establish and verify clinical need

  • Determine total market size

  • Evaluate cost of current treatment options and identify customer cost saving opportunities to help make the economic case for adoption of the new technology

  • Evaluate competitive products and technologies

  • Establish pricing targets and estimate the total market opportunity

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