Quality & Regulatory

DISCIPLINES

Quality & Regulatory Support

We build quality and regulatory requirements into your program from the start. Our design controls, risk management, and documentation prepare your device for regulatory review and a smooth transfer to manufacturing.

Overview

Quality and regulatory support runs alongside every stage of formal development. We enable biomedical innovators to work under design controls through our quality management system, conduct formal design reviews, manage risk throughout the device lifecycle, and maintain documentation in a project file or design history file. We also support regulatory submissions and the quality systems our clients rely on. The result is a device with the documented evidence needed for submission and commercial manufacturing.

Design Review

Formal, documented design reviews at each stage that confirm requirements are met and the program is ready to proceed.
Risk Management

Risk analysis, evaluation, control, and monitoring of residual risk throughout the device lifecycle.
Quality Management Support

Support for implementing or maintaining quality management systems, including design controls, process controls, CAPA, and audits.
Regulatory Support

Assistance with 510(k), PMA, and IDE submissions and compliance with quality system regulations.

PHASE 0

Concept Generation

Supports early risk identification.

PHASE 1

Concept Development

Supports design control documentation for the design history file.

PHASE 2

Design & Development

Leads design controls, design reviews, and risk management.

PHASE 3

Verification & Validation

Leads final design review, risk closure, and submission support.

PHASE 4

Design Transfer

Supports risk management completion and the device master record.

Testing

Confirm performance with biocompatibility, feasibility, verification, and validation testing.
Material Sourcing

Source and manage equipment, tooling, components, and third-party services.
Ideation

Explore the clinical need, select the strongest concepts, and protect the IP created along the way.
Design

Create safe, effective devices that integrate user needs, ergonomics, and aesthetics.
Engineering

Mechanical, electrical, systems, software, and process engineering for complex devices.
Prototyping

Build and test prototypes from early feasibility through verification and validation.
Quality & Regulatory

Maintain design controls, risk management, and regulatory compliance throughout development.