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Certification Process Timeline Overview

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Onur Kaya
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10 views1 page

Certification Process Timeline Overview

Uploaded by

Onur Kaya
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

Certification Process Timeline

Define the product’s:


ͳ Intended use

ͳ Target audience

DEFINE
Patient – age group, benefit of use
Healthcare workers – benefit of use

ͳ Risk to patient
Time frame for potential injury
Severity and permanency of injury

ͳ Desired sales market(s)

1-2 meetings

Determine for each desired market:


Can differ for each country/region and product risk classification.
DETERMINE

ͳ Conformity assessment route


Product type defined/recognized
Risk classifications
E.g. MDR (EU) or UK-MDR 2022 (UK)

ͳ Certification procedure
E.g. CE mark approval by notified body (EU) or UKCA (UK)

ͳ Registration process
E.g. Annual FDA registration (Title 21 CFR Part 807) (USA)

ͳ Need for distributors/importers/local representatives

1-2 meetings per country / region


PLAN

Scope / Plan
2-3 days
IMPLEMENT

Create Establish Initiate


Technical File QMS Certification Process
4-6 months 2-3 months ~ 6 months

Certification
Process
12-18 months

APPROVAL
Can now be sold in this market

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