Achieving regulatory compliance and market access for your medical devices, IVDs, and cosmetics can be complex. Russell Regulatory provides a complete range of services to guide you through every step of the process, from initial strategy to post-market surveillance. Our expert team offers tailored solutions to meet your unique needs, ensuring your products meet the highest standards and reach your target markets efficiently.
Our Services
Our expert team provides the following key services.
Regulatory Services
Our medical device regulatory services cover all aspects of regulatory compliance. We offer expert guidance on strategy development, technical file compilation, clinical evaluation reports, QMS implementation, market authorization submissions, and post-market surveillance. We ensure your medical devices meet the highest standards and reach your target markets efficiently.
Quality Management Services
We help you establish and maintain a robust Quality Management System (QMS) that meets ISO 13485 requirements. Our quality management services include QMS implementation and gap analysis, internal audits, supplier qualification, risk management, and corrective and preventive action (CAPA) support.
UK Responsible Person
Appoint a UK Responsible Person to ensure compliance with UK regulations for both medical devices and cosmetics. We act as your authorized representative, fulfilling all legal obligations and ensuring your products meet UK market requirements.
Clinician Bank
Access our network of qualified clinicians for expert support with clinical evaluations, academic papers, and other clinical aspects of your regulatory submissions. Our clinician bank provides a valuable resource for medical device, IVD, and cosmetic companies.
Cosmetics Regulation
With our expert guidance, you can manage the challenges of cosmetic regulations. We offer support with product safety assessments, labelling compliance, ingredient reviews, and notification and registration processes.
Training
Enhance your team’s regulatory knowledge with our comprehensive training programs. We offer courses on medical device regulations, IVD regulations, cosmetic regulations, and quality management systems.
What Our Clients Say
We value the relationships we build with our clients and are proud of the positive impact we’ve had on their businesses. Read testimonials from medical device and cosmetic manufacturers who have partnered with us for regulatory success. Real results. Real feedback.
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.
Martine Hallows
Amy has worked with myself and SRG on several Regulatory projects for our Medical Device clients. All projects have been completed successfully and references have been great. I would recommend Amy to anyone looking for a specialist consultant in this space!
Laith Mustafa
I’ve had the pleasure of working with Amy since the beginning of her contracting journey, and over the past eight years, she has provided invaluable support to several of our clients. The feedback on her work has consistently been outstanding, and I hope we have the opportunity to collaborate for many more years to come!
Nathan Puxty
Your Trusted Regulatory Partner
At Russell Regulatory, we’re more than just consultants. We are your trusted partners in managing the complex world of medical devices, IVD, and cosmetic regulations. Our team has extensive experience and in-depth knowledge, ensuring you receive accurate, up-to-date guidance and support.
We’re committed to delivering exceptional medical device regulatory services, helping you achieve compliance and market access efficiently. Our tailored solutions are designed to meet your unique needs, whether you’re a startup developing an innovative medical device or an established company seeking to expand into new markets.
Partnering with Russell Regulatory means gaining a dedicated team committed to your success. We provide clear communication, proactive support, and a results-oriented approach, ensuring your regulatory journey is as smooth and efficient as possible.
