I will do ukca certification amazon ebay

A
abbas1215
A
abbas1215
Gabriel Iso

Level 2

5.0
5.0

About this gig

I have knowledge of MDR (medical device regulation) for the UKCA marking of medical devices.

Devices can be classified into the following categories:

  • Class I - generally regarded as low risk FOR UKCA MARKING
  • Class IIa - generally regarded as medium risk FOR UKCA MARKING
  • Class IIb - generally regarded as medium/high risk FOR UKCA MARKING
  • Class III - generally regarded as high risk FOR MDR

Class I devices can be further split into three 'subclasses':

  • Is - sterile device
  • Im - device with a measuring function 
  • Ir - is a re-usable device (i.e. surgical equipment)
  • Related to Technical file toys , machine, surgical, dental, Instruments


Following Documents will be Provided under UKCA MDR in my service plan

  1. Declaration of Conformity
  2. Design & Manufacturing Information
  3. General Safety & Performance Requirements
  4. Harmonized Standard Compliance
  5. Risk Management Plan
  6. Risk Management Report
  7. Verification & Validation Report
  8. Post Market Surveillance
  9. Packaging & Labelling
  10. CER Plan.
  11. Undertaking.
  12. Technical File Summary
  13. CER (Clinical Evaluation)
  14. BER (Biological Evaluation)
  15. IFU


Get to know Gabriel Iso

Gabriel Iso
4.6(13)

Level 2

  • FromPakistan
  • Member sinceJan 2023
  • Avg. response time1 hour
  • Last delivery3 weeks
  • Languages

    English, Urdu, Arabic
Explore our ISO Certification Services to elevate your business standards. Our expert team specializes in ISO 9001, ISO 14001, and ISO 45001, ensuring seamless compliance and optimal quality management. Achieve and maintain international benchmarks with our proven track record in strategic process optimization and continuous improvement
Reviews

1 reviews for this Gig
5.0

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Rating Breakdown
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    lylia_khan

    DZ

    Algeria

    5

    Professional work for getting CE certification and Technical Documentation Highly recommended!!!

    Up to $50

    Price

    2 days

    Duration

    Helpful?
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Reviews

1 reviews for this Gig
5.0

(1)
(0)
(0)
(0)
(0)
Rating Breakdown
  • Seller communication level
    5
  • Quality of delivery
    5
  • Value of delivery
    5
Sort By
Most relevant
  • L
    image-docs

    lylia_khan

    DZ

    Algeria

    5

    Professional work for getting CE certification and Technical Documentation Highly recommended!!!

    Up to $50

    Price

    2 days

    Duration

    Helpful?
    Yes
    No