DESIGN CONTROLS & RISK MANAGEMENT

When designing a new medical device, in order to receive market approval from regulatory bodies such as the FDA, European Commission, Health Canada and so on, it is critical that you demonstrate that your device is safe, effective, and meets the user’s needs and requirements.

This proof is known as Design Controls.

Every regulatory body in the world has some form of required Design Controls that your product must satisfy in order to acquire market approval.

Best practices dictate that Design Controls and Risk Management be integrated during your product development process.

While the correlation between Design Controls and Risk Management is very strong, they approach the design, development, and manufacturing of medical devices from slightly different perspectives.

At Delta Consulting Alliance, we have a proven, step by step process for ensuring you are able to bring new product to market through comprehensive and integrated design controls and risk management.

510(k) Premarket Notification Background

Our Process

step 1

First, we do a deep dive into your company, your people, and the product(s) or services that you wish to design and develop so we have a thorough understanding of your current situation.

step 2

We scrutinize the policies, processes, practices, procedures, and systems that you already have in place.

step 3

We perform a “gap analysis”, identifying the gaps in your current policies, processes, practices, procedures, and systems and identify how those gaps can be filled.

step 4

Starting with the Management and the Design Group, we implement any tools, such as an eQMS system, and set the foundation for the Design and Development Process, including Enterprise Risk Management and Product Safety Risk Management.

step 5

Delta Consulting Alliance augments your existing team, as determined applicable, through consultation with the Management Group and the Design Group. The supplemental group is only used as necessary, making access to our expertise much less expensive than hiring Full Time Employees.

Here are some of the areas of expertise Delta can provide to your team:

Planning and Project Management
Risk Management
Design Controls
Human Factors and Usability Engineering
Electronic Quality Management System (eQMS)
Clinical and Scientific Support

Regulatory Affairs
Intellectual Property Law
Marketing for Medical Devices
Supply Chain Sourcing and Management
Validation
Training

step 6

We scrutinize the policies, processes, practices, procedures, and systems that you already have in place…

step 7