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I will provide eu mdr ce and iso 13485 mediacal device certification
FDA specialist for US FDA registration
Hi, I’m Claudia, a certified regulatory & compliance specialist with 500+ successful projects delivered and 300+ client recommendations worldwide. I provide ISO certification documentation & QMS manua...
About this Gig
Need a fully compliant EU MDR CE technical file, ISO 13485 QMS documentation, or regulatory dossier for your medical device? I specialize in preparing accurate, audit-ready technical files, CE marking submissions, ISO 13485 SOPs, and QMS documentation for medical device manufacturers, startups, and exporters targeting the EU market.
My Services Include:
- EU MDR technical file creation (Annex II/III)
- CE marking submission & compliance reports
- ISO 13485 QMS documentation, SOPs, procedures
- Gap analysis, risk management, post-market surveillance
- Regulatory dossier review & organization for notified bodies
Why Choose Me:
- Proven expertise in EU MDR, CE marking, ISO 13485, QMS, and medical device regulatory compliance
- Fast turnaround with 100% audit-ready, accurate documentation
- Confidential, professional service tailored to manufacturers & startups
Lets get your medical device CE-certified,ISO 13485-compliant, and submission-ready.
ORDER NOW or MESSAGE ME NOW!! to prepare your complete regulatory dossier today!!
Type of Business:
LLC
•
LTD
Service type:
State business registration
Target country:
Worldwide
•
United Kingdom
•
United States
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My Portfolio
FAQ
1. What EU MDR CE certification services do you provide for medical devices?
I provide EU MDR CE certification services for medical devices, including EU MDR compliance, CE marking under EU MDR, medical device CE certification, EU MDR consulting, EU MDR technical documentation, EU MDR regulatory compliance, and CE marking for Class I, Class IIa, Class IIb, and Class III
2. Do you offer ISO 13485 certification for medical device manufacturers?
Yes, I provide ISO 13485 certification services, ISO 13485 consulting, ISO 13485 implementation, ISO 13485 documentation, and ISO 13485 quality management system (QMS) certification for medical device manufacturers, medical device companies, and medical device startups.
3. Can you help with both EU MDR CE marking and ISO 13485 certification together?
Absolutely. I offer a complete EU MDR CE marking and ISO 13485 certification package for medical devices, combining EU MDR regulatory compliance, CE certification, and ISO 13485 QMS certification. This EU MDR + ISO 13485 medical device certification service reduces cost, saves time.
4. What types of medical devices do you support for EU MDR and CE certification?
I support Class I, Class IIa, Class IIb, and Class III medical devices, including software as a medical device (SaMD), IVD medical devices, implantable medical devices, diagnostic medical devices, and digital health devices. My EU MDR CE certification services cover all medical device risk classes u
5. Do you prepare EU MDR technical documentation and files?
Yes, I prepare EU MDR technical documentation, EU MDR technical files, CE marking technical documentation, clinical evaluation reports (CER), risk management files (ISO 14971), post-market surveillance (PMS),PMCF plans, and EU MDR compliance documentation required for medical device CE certification
6. Can you assist with Notified Body submission and CE marking approval?
Yes, I provide Notified Body submission support, EU MDR Notified Body consulting, CE marking application assistance, and medical device CE approval support. My EU MDR CE certification service helps ensure smooth Notified Body audits, faster CE marking approval, and full EU regulatory compliance.
7. Do you offer ISO 13485 documentation and audit support?
Yes, I provide ISO 13485 documentation, ISO 13485 quality manuals, ISO 13485 SOPs, ISO 13485 audit preparation, internal audit support, and ISO 13485 certification audit assistance. My ISO 13485 medical device certification service ensures successful certification body audits and long-term complianc
8. How long does EU MDR CE and ISO 13485 medical device certification take?
The timeline for EU MDR CE certification and ISO 13485 certification depends on device classification, documentation readiness, and Notified Body availability. Typically, ISO 13485 certification takes 2–4 months, while EU MDR CE marking may take 3–9 months. I optimize timelines through expert EU MDR
9. Do you help startups and new medical device companies with certification?
Yes, I specialize in medical device startup certification,EU MDR CE marking for startups & ISO 13485 certification for new medical device companies. My EU MDR and ISO 13485 consulting services are designed for early-stage medical device manufacturers, innovators, and first-time CE marking applicant
10. Why choose your EU MDR CE and ISO 13485 medical device certification service?
I provide professional EU MDR CE certification, ISO 13485 certification, medical device regulatory consulting, and end-to-end compliance services with fast turnaround, affordable pricing, and 100% EU MDR compliance focus. My EU MDR CE and ISO 13485 medical device certification service is trusted
