Russell Regulatory Consultants Ltd

Russell Regulatory

Russell Regulatory brings a more modern approach to regulatory affairs.

About Us

Russell Regulatory brings a more modern approach to regulatory affairs.

We are a medical device quality and regulatory consultancy founded in 2018. Since our inception, we’ve worked with clients across the globe, helping them to understand the legislation around medical devices and bringing products of all device risk classifications to market.

From our office in Glasgow, Scotland, our team of experienced and knowledgeable experts work to aid manufacturers in all areas of therapeutics. By leveraging our expertise, clients can confidently navigate the ever-evolving medical device market and meet regulatory obligations.


Regulatory Services

We offer a variety of regulatory services, including:

• Strategy planning
• Device Classification
• UKCA/CE marking
• Technical File Preparation, GAP Analysis and Updates
• Notified and Approved Body Selection
• Determining Device Testing Requirements

Quality Management Services

We offer services to aid in quality management, including:

• Identification of appropriate QMS standards
• Writing, implementing and operating your QMS
• Document Control and Related QMS Activities Service
• Auditing and Corrective Action Planning and Implementation
• Training and development of your team for your QMS


FutureScot Health and Transformation 2024 Conference

April 2024

Russell Regulatory are now officially offering IVDR services

April 2024

MedTalk Podcast Feature

March 2024