Template

List of Qualified Suppliers

Sven Piechottka · ISO 13485 Templates · Published June 09, 2022

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This is a free template, provided by OpenRegulatory. If you are a user of Formwork, our eQMS software, you can save time by choosing “QMS” on the top menu and “OpenRegulatory Templates” on the left menu, then opening the relevant folder to find this template ready to load into Formwork.

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List of Qualified Suppliers

> NOTE: The purpose of this template is to give an idea of the structure. You are much better off not using a
> word document but excel / sheets for this. Also, write your categories as columns and suppliers as rows -
> this template is reversed due to formatting reasons.

Supplier Documentation Supplier #1 Supplier #2 (...)
Supplier Name: ABC Medical Content GmbH XYZ Medical Content GmbH
Purchase Description: Writing Clinical Evaluation Writing Clinical Evaluation
Supplier Status: Approved Blocked
Quality of Products / Services 3 0
Timeliness / Punctuality 3 3
Cooperation 3 3
Payment Terms 3 3
Average Score: 3 1,8
Date of Last Evaluation: 01-04-2021 01-04-2021
Completed By: Jack Smith (QMO) Jack Smith (QMO)
Non-Disclosure Agreement (NDA) <if existing, link here> <if existing, link here>
Supplier Certification <if existing, link here> <if existing, link here>
Quality Assurance Agreement (QAA) <if existing, link here> <if existing, link here>
Supplier Auditing <if existing, link here> <if existing, link here>
Other Measures

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Sven Piechottka

Sven Piechottka

With a background in political and administrative sciences, my way into regulatory affairs started from a different angle. I focused on the promises of precision medicine during my final year of studies and first joined IBM to help leverage healthcare innovation projects across Germany.

 I then gained most of my regulatory experience while working for Vara (before: Merantix Healthcare), where we built up a quality management system from scratch. For about three years, I coordinated regulatory affairs, led the ISO 13485 certification and CE certification of an AI-based radiology software, and served as data protection officer and quality management officer of the company.
More about me