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
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
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
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
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