“Everyone has a plan, until they get punched in the mouth” - Mike Tyson

Product development is hard. Starting with a good plan is an important first step. The reality is that there will be unanticipated events along the way that require decisive and nimble action. Project success will rely on how well these challenges are navigated. Having an experienced project manager on your side makes all of the difference.

Diatomic Project Managers all have an engineering background and have led the successful development of countless products. They are experts in proactive planning and re-planning, removing obstacles to development along the way, enabling our multi-disciplinary project teams to focus and work efficiently.


Product Strategy + Project Management

Our collaborative and iterative approach ensures client expectations are met, and often exceeded. We work to maintain close contact with our clients to facilitate timely, concise and organized communication. Our project managers make sure your needs are considered every step along the way, so you can sleep well at night. We actively manage project cost, schedule and performance and we also provide a depth of experience in product development that enables us to present many options for meeting project goals, allowing you to choose the path that works best for your specific situation.

• Product Strategy and Business Planning
• Product Definition and Development Planning
• Schedule and Budget Management
• Project Risk Analysis and Management

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Quality + Regulatory Guidance

Navigating the regulatory landscape in medical device development is no small feat. Our quality engineers are here to help every step of the way. Expertise includes creation and maintenance of development documentation to support medical device regulatory submissions, including risk management, quality planning, and verification. Capabilities include implementation and maintenance of quality systems in compliance with the FDA medical QSRs and ISO 13485.

• Product Requirements Specifications
• Hardware Requirements Specifications
• Software Requirements Specifications
• Product Risk Analysis and Management
• Design Failure Modes and Effects Analysis (FMEA)
• Fault Tree Analysis (FTA)
• Design and Software Verification Plans, Procedures and Reports
• Design and Software Verification Testing
• Reliability Planning and Testing
• Process Validation (IQ/OQ/PQ)
• Regulatory Guidance, Safety Agency and Compliance Testing

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