Project management and DHF generation for medical devices.
- Project plans
- Design reviews
- Requirements definition
- Risk management
- Design History File / Device Master Record
- Verification and validation testing
FREE your technical engineers from documentation!
. . . with hassle free regulatory compliance
Mission Statement: Managing and executing clients’ projects from concept, through design and development, to post-market, with a laser focus on efficiently meeting design control and risk management regulatory requirements.
Twenty years of experience developing Class II and Class III medical devices in a regulatory setting for US and EU markets.
Cyclops Engineering can help you navigate the complex challenges of product development in a regulated industry, compliant to ISO 14971, ISO 13485, IEC 60601-1, IEC 62304, and other regulatory standards.
Extensive experience developing:
- Active implants
- Surgical instruments
- Combination drug delivery devices
- Consumables
- IVD’s
Nimble development free of corporate bureaucracy
Project Management
Foresight, experience, and planning early in the project are essential to keeping your project on schedule and on budget.
DHF Creation
A “precision bombing” approach to DHF generation: Understanding exactly what regulatory agencies expect is essential to minimizing risk exposure without wasted effort on “non-value-added” activity.
Regulatory Remediation
Companies with limited resources can often be overwhelmed by regulatory requirements. We can get you back on track quickly.
Owner Brandon Curley has over 20 years of experience developing medical devices.
About Us
Providing medical device product development services throughout the United States.
Cyclops Engineering 