Russell Regulatory Consultants Ltd

Russell Regulatory
Consultants

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.

Services

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

Learn more

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

Learn more

Enormous gratitude to Amy at Russell Regulatory Consultants for their invaluable assistance in preparing my MDR compliant medical technical files. Amy's expertise and meticulous attention to detail ensured all documents met regulatory standards. I highly recommend Amy for anyone seeking top-level support in dealing wit medical products and regulatory compliance.

Russell Regulatory Consultants provide a first class service. Amy provides an excellent depth of knowledge and experience. She helped me in the preparation of platformed technical files containing numerous products. I would definitely recommend her and would use her services in the future if the need arises.

Highly recommend Amy! Very thorough and professional. Amy is currently part of your consultant Team and is key to your MDR transition plan execution.

Working with Amy was very pleasant. She provided us with guidance at the regulatory level to successfully comply with the EU MDR. For a PM it is always key to have responsible , accountable people on our team with a great attitude, anticipating the requirements and thats how Amy is.