Medical device and cosmetic manufacturers face increasing regulatory complexities. Russell Regulatory provides expert medical device consultancy services and guidance on cosmetic compliance to help you through every step.
Regulatory Compliance Expertise
Market Access for Medical Devices, IVDs and Cosmetics
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We offer solutions to ensure your products meet necessary standards, allowing you to focus on innovation and growth. Talk to us.
Expert Medical Device Regulatory Consultancy Services
We offer a complete range of medical device regulatory consultancy services designed to help you manage the challenges of compliance and bring your products to market efficiently.
Regulatory Strategy Development
Develop a clear and effective medical device regulatory strategy that aligns with your product and target market.
Technical File Compilation and Gap Analysis
Ensure your technical documentation is complete and compliant with relevant medical device regulatory requirements.
Clinical Evaluation Reports and Literature Reviews
Generate clinical evidence to support the safety and efficacy of your medical devices, fulfilling medical device regulatory obligations.
Quality Management System (QMS) Implementation
Establish and maintain a secure QMS to meet medical device compliance requirements and ensure product quality.
Market Authorisation Submissions
Prepare and submit successful applications for market authorisation in your target regions, demonstrating regulatory adherence.
Post-Market
Surveillance
Maintain medical device compliance and proactively address any post-market issues.
UK Responsible Person Services
Ensure compliance with UK regulations for both medical devices and cosmetics by appointing a UK Responsible Person. We act as your authorized representative, fulfilling all legal obligations and ensuring your medical devices and cosmetics meet UK market requirements.
Comprehensive Regulatory Solutions
We provide expert regulatory guidance for the medical device, IVD, and cosmetic industries.
Medical Devices
Comprehensive medical device consultancy services for all stages of the product lifecycle.
- Develop winning medical device regulatory strategies.
- Ensure audit-ready technical documentation.
- Generate compelling clinical evidence.
- Tailored solutions for startups, SMEs, and large enterprises.
- Achieve efficient market authorization.
- Maintain post-market medical device compliance.
In Vitro Diagnostics (IVDs)
Specialized expertise in in vitro diagnostics regulations to ensure compliance and market access.
- Manage the challenges of IVDR.
- Demonstrate clinical performance and analytical validity.
- Implement reliable quality management systems.
- Obtain timely market authorization.
- Ensure ongoing post-market surveillance.
Cosmetics
Expert guidance on cosmetic compliance and international regulations, including EU cosmetics regulation.
- Ensure product safety and meet ingredient restrictions.
- Comply with labelling requirements.
- Conduct necessary testing and documentation.
- Comply with international cosmetic regulations.
- Maintain up-to-date knowledge of evolving regulations.
Your Trusted Partner in Compliance
Russell Regulatory is committed to providing expert medical device regulatory consultancy services. Our team of experienced professionals has a deep understanding of global medical device and cosmetic regulations. We work closely with our clients to develop tailored solutions that meet their specific needs and ensure compliance.
Unparalleled Regulatory Expertise
Our extensive knowledge and experience allow us to provide comprehensive support across all aspects of medical device and cosmetic regulations.
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
Meet Your Regulatory Expert
Amy Russell is the Managing Director of Russell Regulatory Consultants, a leading medical device regulatory consultancy. With extensive experience across diverse therapeutic areas, Amy and her team provide expert guidance on MDR transition, technical documentation, clinical evaluation, UK Responsible Person obligations, cosmetics compliance and more. Her mission is to streamline regulatory processes and allow companies to focus on innovation.
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Ways We Can Work Together
We offer flexible engagement models to meet your specific regulatory needs and ensure your continued success.
Projects
Work with Russell Regulatory on a project basis for set, predictable tasks, such as:
- Medical device regulatory strategy development
- Gap assessments
- QMS internal audits
- Technical file compilation
- EU cosmetics regulation compliance projects
- In vitro diagnostics regulatory strategy
We offer clear project fees and deliverables, so you know exactly what to expect.
Specialist Support
Russell Regulatory is an ideal partner for larger or more specialized projects, such as:
- Temporary specialist on-site or remote support for medical device compliance
- Outsourcing of an entire project or assignment
- Complete transition or remediation projects
- UK Responsible Person services
We provide customized quotations based on the scope of your needs.
Retainer
For ongoing support, a monthly retainer provides access to our expert consultants for a set number of hours. This allows you to:
- Get expert answers to your regulatory questions
- Manage specific projects with dedicated support
- Ensure ongoing medical device compliance, cosmetic compliance, and adherence to in vitro diagnostics regulations.
We offer flexible retainer options and competitive rates.