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I will provide eu mdr 2017 technical documentation
About this Gig
Stop letting regulatory hurdles delay your launch. I help MedTech startups and global manufacturers navigate EU MDR (2017/745) and IVDR with zero friction. As a Lead Auditor (5+ years experience), I ensure your files are audit-ready.
What I Offer:
- Technical Files (STED): Compilation of full Summary Technical Documentation.
- Risk Management (RMF): ISO 14971 compliant hazard analysis & FMEA.
- Clinical Suite: Expert preparation of CEP, CER, and BER.
- Post-Market (PMS): Drafting PMSR, PSUR, and PMCF reports.
- EUDAMED & UDI: Actor registration and UDI implementation.
- Authorized EU Rep: Legal liaison with Competent Authorities.
- Gap Analysis: Pre-audit assessments to ensure 100% readiness.
Lets streamline your EU Rep and documentation needs so your medical device is safe, compliant, and ready for the European market.
Document type:
Documentation
•
Regulatory Documents
Language:
English
•
German
Delivery style preference
Please inform the freelancer of any preferences or concerns regarding the use of AI tools in the completion and/or delivery of your order.
My Portfolio
FAQ
Do you provide custom-written files or just templates?
I provide 100% custom-written documentation tailored specifically to your medical device and its classification. I do not use generic templates; every RMF, CER, or STED file is authored to meet the unique technical requirements of your product and ensure it passes Notified Body scrutiny.
Can you help with the transition from MDD to EU MDR 2017/745
Yes. I specialize in gap analysis and remediation. I can review your legacy MDD technical files and upgrade them to meet the much stricter requirements of the new EU MDR, including updated clinical evaluations (CER) and post-market surveillance (PMS) plans.
What information do you need from me to get started?
To begin, I will need the device classification (Class I, IIa, IIb, or III), its intended use, and any existing technical data or ISO 13485 quality manuals you currently have. If you are starting from scratch, we can begin with a Regulatory Roadmap to define your path to market.
Reviews
1 reviews for this Gig
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Rating Breakdown
- Seller communication level
- Quality of delivery
- Value of delivery
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Most relevant
Z 
zevsek
Slovenia
Very professional service provider. He delivered technical documentation that exceeded my expectations. I will definitely hire him again.
$400-$600
Price
6 days
Duration
Z Seller's Response
Helpful?
Reviews
1 reviews for this Gig
| (1) | ||
| (0) | ||
| (0) | ||
| (0) | ||
| (0) |
Rating Breakdown
- Seller communication level
- Quality of delivery
- Value of delivery
Sort By
Most relevant
Z zevsek
Slovenia
Very professional service provider. He delivered technical documentation that exceeded my expectations. I will definitely hire him again.
$400-$600
Price
6 days
Duration
Z Seller's Response
Helpful?
