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:
- 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
