Regulatory Services

Technical Documentation

Comprehensive and compliant technical documentation is key to demonstrating product safety and performance. Regs by Karen Ltd assists manufacturers by preparing, reviewing, and maintaining technical files that meet UK, EU, and global regulatory requirements.

With extensive hands-on experience of writing all aspects of technical documentation including Summary Reports, Stability Reports, Biological Safety Evaluations and Clinical Evaluations, documentation is developed to be clear, complete, and audit-ready.

Additional services include gap analyses and remediation plans — giving you confidence that your products meet the standards expected by regulators and customers alike.

Clinical Evaluations

Clinical evidence is at the heart of medical device compliance. Regs by Karen Ltd provides expert support in planning, preparing, and maintaining Clinical Evaluation Reports (CERs) that clearly demonstrate the safety, performance, and clinical benefit of your products.

With experience across medical device clinical research and regulatory affairs, comprehensive assistance can be provided with all aspects of the clinical evaluation process — from scoping and literature review strategy through to data appraisal, gap analysis, and ongoing updates.

Support can be provided whether you need a full CER, a revision to meet evolving regulatory expectations, or help integrating PMS and PMCF data, ensuring your evaluations are robust, well-reasoned, and fully aligned with UK, EU, and international requirements.

The focus is on producing clinical evidence that stands up to scrutiny, supports timely approvals, and provides a strong foundation for your product’s lifecycle compliance.

Post Market Surveillance

Effective post-market surveillance (PMS) is essential to maintaining compliance and ensuring ongoing product safety. Regs by Karen Ltd supports manufacturers in developing and implementing PMS systems that meet regulatory expectations and deliver meaningful insights.

Services include preparing post market surveillance plans, establishing data collection processes, conducting trend analysis and producing post market surveillance reports/PSURs. Clear, reliable guidance is provided throughout to help you stay proactive and responsive in a regulated environment.