Start Here

Start with what your company needs now.

Building a medical-device quality system can feel like being handed a map with every road marked urgent. Groundwork helps you identify what your company needs now, what can come later, and how the pieces should work together.

Begin with where you are

Defining the foundation
Clarify your product, intended markets, company responsibilities, development approach, and the records you will need to create from the beginning.

Building the core quality system
Establish document control, training, design and development controls, risk management, supplier controls, and the other processes appropriate to your device and business.

Preparing for commercialization
Connect complaints, nonconforming product, CAPA, change control, installation, service, and postmarket activities before customers begin depending on the device.

Choosing the right systems
Define the process before selecting the software. Groundwork provides independent guidance for evaluating eQMS, CRM, document control, field service, and other operating tools without buying more system than your company needs.

Start with a clear view of the work ahead
Download the free Medical Device Startup SOP Checklist to identify the procedures and records your company may need, who typically owns them, and when they usually become important.