ISO 13485 document template:

Technical File Procedure

A procedure that describes how to prepare the Technical File and how to complete the individual sections. It also indicates what needs to be taken into account when verifying that individual reports have been prepared in accordance with the requirements of the MDR and other relevant regulations.

The document is optimized for small and medium-sized organizations - we believe that overly complex and lengthy documents are just overkill for you.

There are 4 appendices related to this document. The appendices are not included in the price of this document and can be purchased separately: Technical File Template and Technical Documentation Checklist, Summary of Safety and Clinical Performance and List of UDI-DI.

RELATED DOCUMENTS Summary of Safety and Clinical Performance List of UDI-DI Technical Documentation Checklist Technical File Template

US $79.90

Proceed to checkout

CUSTOMERS FROM 107 COUNTRIES

100% secure online billing
AES-256bit SSL safe

RELATED DOCUMENTS Summary of Safety and Clinical Performance List of UDI-DI Technical Documentation Checklist Technical File Template

THIS TEMPLATE IS ALSO AVAILABLE AS PART OF THIS DOCUMENTATION TOOLKIT

ISO 13485 & MDR Integrated Documentation Toolkit

SEE PRICING & OPTIONS

DOCUMENT FEATURES

OVERVIEW

Price
US$ 79.90
Compliant with
MDR Annex II
Format
MS Word 2013, MS Word 2016, MS Word 2019
Number of pages
6
Document language
English

USABILITY

Can I edit the document?
Yes. The document is fully editable – just enter information specific to your company.
Can I use this to become certified?
Yes. The documentation template may be used for ISO 13485 certification audit purposes.
Well-defined instructions
Document templates contain an average of twenty comments each, and offer clear guidance for filling them out.
Designed with your company in mind
The template was created for small and medium-sized businesses.

WHAT OUR CUSTOMERS SAY ABOUT US

The documents are well laid out and with our company’s standard formatting they are just falling into place.

Thomas Green

CBCP

Simple gave us an example of how the document could be structured and the different fields to include. Helped us not leave anything out.

Wynn Johansson-Nunez

SVENSKA DENTORAMA AB.

OUR CLIENTS

Preview Technical File Procedure template

The document is fully editable so that you can adapt it to your company design.
Documents include placeholder marks for all information you need to complete.
Each document includes comments and information, which guides you through completion.

Preview Technical File Procedure template

VIEW FULL-SIZE PREVIEW

Buy Technical File Procedure

US $79.90

Buy now

Sold in 107 countries

100% secure online billing
AES-256bit SSL safe

FAQS: BUYING INDIVIDUAL ISO 13485 DOCUMENT TEMPLATES

How will l receive the template?

After payment confirmation, we'll send you an email that contains a link to download the document. It's super easy.

What payments do you accept?

You may pay with major credit card, or via wire transfer from your bank account.

How do you protect my payment details?

We use Secure Socket Layer (SSL) technology, which is the industry standard and considered one of the safest systems for online payment. Your account details and credit card information are encrypted and go straight to the payment processor. We won’t have access to your payment information, and we won’t store it in any form.

Which currencies are accepted?

We can accept 50-plus common currencies for payment, including Swiss Francs, US Dollars, British Pounds and Euros.

Conformio

ISO 13485 Documentation Toolkits

ISO 13485 Training

By Type

By Standard

Other

Kristina Zvonar Brkic