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I will act as eu authorized representative for medical devices
Certified Regulatory Affairs Professional for Medical Industry
Medical Devices Regulatory & Compliance Expert with extensive experience in international standards, regulations, directives, and guidelines for the medical device industry. Specialized in EU MDR, CE ...
Level 2
Has met high performance criteria and has a proven track record for meeting client expectations.
About this Gig
### EU Authorized Representative Services
Need help with MDR/IVDR compliance? I offer **EU REP services** to non-EU medical device manufacturers.
### **Services:**
- **EU REP:** Legal representation for compliance
- **Registration:** EUDAMED and national database support
- **Documentation:** Ensure EU standards compliance
- **PMS:** Incident reporting and FSCA management
- **Liaison:** Contact with EU authorities and Notified Bodies
- **Ongoing Support:** Continuous compliance assistance
### **Why Choose Me?**
- **Expertise:** 15 years in medical device regulations
- **Reliability:** Professional support
- **Cost-Effective:** Tailored services
### **For:**
- Non-EU manufacturers
- Companies seeking compliance
- Startups and SMEs entering the EU
### **Process:**
1. **Contact Me:** Share your device details
2. **Agreement:** Sign a mandate
3. **Compliance Support:** I handle regulatory tasks
4. **Market Access:** Ready for the EU market
**Let's Get Started!** Contact me for seamless EU market entry!
Business type:
Startups
•
SMBs
Service type:
Compliance & regulatory
•
Supply chain risks
Industry:
Legal
•
Medical & pharmaceutical
•
Retail & wholesale
My Portfolio
Other Business Consulting Services I Offer
FAQ
Q: What is an EU Authorized Representative?
A: An EU REP is a legal entity based in the EU that represents non-EU manufacturers, ensuring compliance with MDR/IVDR.
Q: How long does it take to appoint an EU REP?
A: The process typically takes 2-4weeks, depending on the complexity of your devices.
Q: Can you help with MDR/IVDR transition?
A: Yes, I provide support for transitioning from MDD to MDR or IVDD to IVDR.
Q: Do you work with startups?
A: Absolutely! I offer tailored solutions for startups and SMEs entering the EU market.
Q: What documents do I need to provide?
A: You’ll need to share your technical documentation, declarations of conformity, and device details. I’ll guide you through the process.
Reviews
11 reviews for this Gig
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Rating Breakdown
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- Quality of delivery
- Value of delivery
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M maroen_pioss
United States
It's great working with someone so knowledgeable and helpful.
1 day
Duration
Helpful?N noagaelle
United States
A true expert in their field! The seller understood my vision perfectly and delivered a stunning final product ahead of schedule!
2 days
Duration
Helpful?T 
touchstonee
Canada
The seller was professional, responsive, and delivered high-quality work. The final result exceeded my expectations. Will hire them again!
1 day
Duration
Helpful?L lunethar
United States
The seller provided excellent service and delivered high-quality work on time. The process was stress-free, and I’m very satisfied. Will hire them again!
2 days
Duration
Helpful?M 
mercerlawson
United States
Demonstrating remarkable professionalism, the seller ensured all project specifications were met, providing a final result of exceptional standard.
1 day
Duration
Helpful?
Reviews
11 reviews for this Gig
| (11) | ||
| (0) | ||
| (0) | ||
| (0) | ||
| (0) |
Rating Breakdown
- Seller communication level
- Quality of delivery
- Value of delivery
Sort By
Most relevant
M maroen_pioss
United States
It's great working with someone so knowledgeable and helpful.
1 day
Duration
Helpful?N noagaelle
United States
A true expert in their field! The seller understood my vision perfectly and delivered a stunning final product ahead of schedule!
2 days
Duration
Helpful?T touchstonee
Canada
The seller was professional, responsive, and delivered high-quality work. The final result exceeded my expectations. Will hire them again!
1 day
Duration
Helpful?L lunethar
United States
The seller provided excellent service and delivered high-quality work on time. The process was stress-free, and I’m very satisfied. Will hire them again!
2 days
Duration
Helpful?M mercerlawson
United States
Demonstrating remarkable professionalism, the seller ensured all project specifications were met, providing a final result of exceptional standard.
1 day
Duration
Helpful?
