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I will compile ukca marking technical files for medical and electrical devices
Benita Jane
About this gig
Navigating UK regulatory compliance can be complex, but getting your medical or electrical devices onto the UK market doesn't have to be overwhelming. As a regulatory affairs professional with deep expertise in UKCA compliance, I provide meticulous, audit-ready technical file compilation services aligned with current UK MDR and relevant electrical safety regulations.
Whether you are launching a brand-new product or transitioning legacy documentation, I will structure, review, and finalize your technical documentation to meet rigorous MHRA and UK approved body standards.
What my service includes:
- Comprehensive Essential Requirements / General Safety and Performance Requirements (GSPR) checklists
- Risk management file review and integration (ISO 14971)
- Electrical safety and performance test report coordination/summary
- Clinical evaluation and post-market surveillance (PMS) plan integration
- Full technical dossier structuring for seamless audit submission
Save time, avoid regulatory delays, and ensure absolute market readiness. Order today or message me to discuss your specific device classification!
Get to know Benita Jane
Benita Jane
UK Regulatory Affairs and Clinical Compliance Consultant
- FromUnited Kingdom
- Member sinceOct 2026
Languages
English
Deliver rigorous compliance for UK healthcare markets with specialized regulatory expertise. I assist pharmaceutical distributors, medical device manufacturers, and clinical researchers in navigating stringent MHRA standards. My core services encompass compiling audit-ready UKCA technical files, managing Yellow Card adverse event reporting workflows, drafting GDP-compliant standard operating procedures, and auditing Trial Master Files for GCP compliance. Ensure seamless market entry, maintain absolute audit readiness, and protect your operations today.
FAQ
What types of devices do you cover for UKCA marking?
I cover general medical devices (Class I, IIa, IIb) and various electrical/electronic equipment subject to UK conformity assessment regulations.
Do you provide the actual testing for electrical safety?
I compile, summarize, and integrate existing test reports into your technical file; I do not perform laboratory testing directly.
What standards do you align the technical files with?
Files are structured according to current UK legislation, UK MDR 2002 (as amended), and relevant British/harmonized standards.
Will my technical file be ready for an Approved Body review?
Yes, the compilation follows structured regulatory formats designed to withstand scrutiny from UK Approved Bodies and the MHRA.
What do you need from me to get started?
I will need your device description, intended use, existing test reports, risk management files, and user manuals.
Can you update my old CE mark technical file for UKCA compliance?
Absolutely. I specialize in converting and updating legacy documentation to meet contemporary UKCA regulatory requirements.
Do you offer ongoing post-market surveillance support?
Yes, post-market surveillance plans and vigilance procedure alignment can be added or included in higher-tier packages.
