Accelerating Medical Device Innovation

Services

Here are just some of our areas of expertise. We are supported by a network of associates enabling us to identify the right expert to apply to your challenge.

Product Development

• Project Management
• Requirements Definition
• Risk Management
• Verification & Validation

Quality Management Systems (QMS)

• Creation, implementation and certification of an ISO 13485 compliant QMS.
• Broaden scope to include US FDA regulation.
• Audit preparation

Regulatory Compliance

• Determination of intended use and device risk classification
• Identification of applicable regulations and standards
• Documentation

Due Diligence

• Find out how we can help you manage your investment risk.