I will do iso 13485, ce mark with rep, doc, eudamed and mdr documentation


Level 1
About this gig
Looking for ISO 13485, CE, EU REP, EUDAMED/ SRN & MDR Documentation.
Then I can help you.
I am sure that it's a challenge to prepare documentation and get ISO 13485, CE, EUDAMED/ SRN & MDR But these are mandatory Requirements to place medical devices in European Market.
ISO 13485:2016 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.
The European Authorized Representative (EC REP) performs certain duties under the European Medical Devices Regulations and acts as the legal interface between the Medical Device manufacturer and the EU Authorities.
Under the new MDR (EU) 2017/745 Authorized Representatives (EC Rep) have greater responsibilities and take on significantly more risk and liabilities, therefore you can expect your representative to scrutinize your documentation more thoroughly.
The declaration of conformity certificate will also be provided to you.
Drop a message and discuss with our experts.
- Note: Contact us before placing an order.
Get to know Areej
Marketing Executive at PGCS
Level 1
- FromPakistan
- Member sinceNov 2022
- Avg. response time1 hour
- Last delivery3 months
Languages
Urdu, English
My Portfolio
Other Regulatory Compliance Consulting Services I Offer
FAQ
Do offer ISO 13485 Documentation and its Revision?
Yes, I'm offering these services.
Is it necessary to get EU Rep and SRN to place products in European Market?
Yes, its compulsory for every Non-European Manufacturer.
1 reviews for this Gig
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H hamza099825
Repeat Client

Pakistan
Areej delivered exceptional work with professionalism and exceeded my expectations in strategic business planning. The level of cooperation and politeness made everything run smoothly and on time. I look forward to continuing our future projects together! 👍
Up to $50
Price
9 days
Duration
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1 reviews for this Gig
| (1) | ||
| (0) | ||
| (0) | ||
| (0) | ||
| (0) |
Rating Breakdown
- Seller communication level
- Quality of delivery
- Value of delivery
Sort By
H hamza099825
Repeat Client

Pakistan
Areej delivered exceptional work with professionalism and exceeded my expectations in strategic business planning. The level of cooperation and politeness made everything run smoothly and on time. I look forward to continuing our future projects together! 👍
Up to $50
Price
9 days
Duration
A 
Seller's Response
Helpful?

