About Practical QA/RA

Experienced Experts

Practical QA/RA brings together 25 years of expertise in Medical Device Quality Assurance and Regulatory Affairs, complemented by accessible clinical insights. This unique combination ensures that the voice of the customer is to device development and maintained throughout the product life cycle. Our commitment is to quality and compliance while prioritising user needs.

Dr. STEPHEN SMITH

Lead Consultant, Co-Founder

Stephen started his journey in Quality Assurance and Regulatory Affairs in Medical Devices in 1999. Starting as an internal auditor he went through the ranks to being a QA/RA Director leading teams of up to 25 internationally. Over this time he has seen vast changes in technology, regulation, perception and practice.

Dr. MARIA VELLA

Clinical Advisor, Co-Founder

Maria is a Consultant Obstetrician and Gynaecologist and brings a necessary clinical eye to the table. In her 25 years clinical experience she has seen great medical devices that she has used repeatedly and ones which she has tried once and never used again - whilst also telling colleagues of the experience.

An In-Depth Understanding

It’s crucial to understand both the clinical need and the needs of your customers for a device to succeed. Many companies may think they have a grasp on this, but true insight comes from collaboration real users. Documenting these needs and recognising potential risks is essential—after all, no customer means no device.

Additionally, remember that without the necessary regulatory approvals, your device won’t reach the market; therefore, consider the regulator as a key customer and involve them as a design input from the very beginning.