Startups and Incubators

Cirtec offers medical device start-ups a toolkit of essential services, which help our clients achieve a clear advantage by leveraging our experience and expertise. These services give startups access to the same level of expertise as the largest medical device manufacturers. This tool-kit includes:

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  • Cirtec’s project plans featuring detailed, line-by-line descriptions of every task required to implement the project. These plans are often used as a key tool to present important milestones and funding requirements to potential investors and they can be tailored to coincide with funding milestones as desired.
  • Detailed requirements specifications based on top level user needs. This results in an established engineering path as well as a basis for meeting regulatory requirements.
  • Dedicated engineering and manufacturing staff so that you don’t have to hire an entire team of direct reports. This enables start-up customers to keep a tight control of costs.
  • Office space for keeping your overhead to a minimum.
  • Principal engineers and industry experts that can help close your deal with investors and potential acquisition partners.
Quality System

Cirtec provides a suite of quality services which range from:

  • Single procedure development.
  • Implementation of an entire Quality System compliant to 21 CFR Part 820 and ISO 13485:2003.
  • Monthly compliance visits to client sites for Quality services including auditing, training, document control and records management.
  • Selection and qualification of client supply chain through robust auditing. 
Information Technology

Cirtec offers a full array of IT services for startups & incubators including:

  • IT consulting services
  • Network engineering services
  • Infrastructure design & implementation for LAN/WAN environments
  • Technical support
  • Disaster recovery
  • Document control
  • Remote management
  • Compliance & validation with ISO/FDA