Services
Your Journey Begins Here
Working through a simple, structured pathway, organisations are guided to navigate regulatory requirements, build the right quality framework and launch products to the market, enabling patients/customers to have access to safe and effective products. Let me help guide you along the entire pathway or provide advice and support at any step along the way.
Regulatory Services
Navigating global regulatory requirements can appear complex and time-consuming. Regs by Karen Ltd offers tailored regulatory support to help you understand and meet the obligations for your medical devices, IVDs, cosmetics, and related products.
From strategy and submissions to compliance maintenance, we provide clear, practical guidance that keeps your products on the market and your business moving forward with confidence.
Explore our Regulatory Strategy Services:
- Technical Documentation
- Clinical Evaluations
- Post Market Surveillance
Quality Management Systems
A strong Quality Management System (QMS) is essential for compliance and continuous improvement. Whether you’re building a system from scratch or refining existing processes, Regs by Karen Ltd will support you in developing, implementing, and maintaining QMS frameworks that meet ISO 13485 and other relevant standards, ensuring your QMS is both compliant and effective in driving quality throughout your organisation.
Explore our Quality Assurance Services:
- Quality Management Systems (QMS)
- Risk Management
Product Registration
Bringing products to market requires accurate, timely, and compliant registration activities. Regs by Karen Ltd provides comprehensive support across UK and EU frameworks - from early planning and preparation through to submission, maintenance, and communication with regulators or Responsible Persons.
This end-to-end approach helps ensure your devices and products meet all necessary requirements, enabling smooth market access and long-term compliance.
Explore our Product Registration Services:
- UK Responsible Person (UKRP)
- UK & EU Product Registrations
- Cosmetic & General Product Compliance
Contact me today
Whether you have a question about my services, need assistance with a specific regulatory challenge, or simply want to learn more about how I can help you achieve compliance and market success. Book a free 30 minute Discovery Call or send a contact request today.
Discovery Call Contact