I will do mhra registration, ukca certificate, fda registration eu mdr documentation


About this gig
Planning to launch your medical device in the UK, EU, or USA with full compliance?
You're in the right place.
I am a regulatory affairs consultant specializing in medical device compliance for startups, manufacturers, and exporters. I help clients achieve fast mhra registration, ukca marking, and fda compliance with accurate documentation and smooth approval processes.
Services include mhra registration (UK authority for medical devices), ukca certificates and declarations of conformity, and UK responsible person (UK RP) support. I also handle fda registration, fda documentation, EMA eCTD modules, eu mdr technical file, ce marking, ISO 13485 documentation, and EC certificate of conformity.
I deliver complete compliance for mdr, fda, ukca, and global markets, including technical writing, SOP writing, risk management, GMP, SDS, and product compliance documents.
I also support cosmetics, supplement, and food safety projects such as food registration, food labeling, food compliance, and FSVP agent services.
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Get to know Catherine
TOP R
- FromUnited States
- Member sinceMar 2026
- Avg. response time2 hours
Languages
English
FAQ
What regulatory services do you provide for medical devices?
I offer mhra registration, ukca marking, fda registration, and full fda compliance support. I also prepare eu mdr technical file, ce marking documents, ISO 13485 documentation, and complete regulatory affairs consulting for medical devices.
Can you help non-UK or international manufacturers enter the UK market?
Yes. I support international clients with mhra registration, uk responsible person (UK RP) services, and ukca certification. I ensure full uk compliance so your medical device meets all regulatory requirements.
Do you provide documentation only or full compliance support?
Both. I deliver technical writing services such as technical file, SOP writing, risk management, GMP, SDS, and fda documentation. I also provide full consulting from registration to product compliance approval.

