ISO 13485 & MDR INTEGRATED DOCUMENTATION TOOLKIT

Implement ISO 13485, ISO 14971 and EU MDR without using a consultant.

Step-by-step guidance with LIVE EXPERT SUPPORT

  • 101 document templates – unlimited access to all documents required for ISO 13485 certification, for ISO 14971 and EU MDR, plus commonly used non-mandatory documents

    Editable MS Word and MS Excel policies, procedures, plans, and forms that you can adapt to your company needs.

  • Email support

    We will answer your questions within 1 business day. You can send up to 10 questions per month.

  • Expert review of a document

    After completing the document, you can send it for our review, and we’ll give you our comments on what you need to improve to make it compliant with the standards.

  • One hour of live one-on-one online consultations
    with an ISO 13485 expert

    Our expert will speak to you via Skype or telephone, at a time that’s convenient for you, where you can discuss how to resolve any issues you face in the implementation; the expert will also provide tips on the next steps in your project.

Fully optimized for
small and medium-sized companies

997 EUR
PROCEED TO CHECKOUT DOWNLOAD FREE DEMO

CUSTOMERS FROM 107 COUNTRIES

payment cards
security key image 100% secure online billing
AES-128bit SSL safe
Want to see what the documents look like?

Schedule a free presentation, and our representative will show you any document you're interested in.

ISO 13485 & EU MDR TOOLKIT:

RIGHT FOR YOUR BUSINESS?

ISO 13485 & MDR Integrated Documentation Toolkit - 13485Academy

Are you small or medium-sized company?

ISO 13485 & MDR Integrated Documentation Toolkit - 13485Academy

Are you looking to minimize time and cost of implementation?

ISO 13485 & MDR Integrated Documentation Toolkit - 13485Academy

Are you searching for concise and easy-to-use templates?

We understood your needs, found the answers to your questions, and developed ISO 13485 & EU MDR Documentation Toolkit especially for your company. Our toolkit doesn’t require completion of every document that a large world-wide corporation needs. Instead, it includes only those documents YOUR business needs.

WHY CHOOSE the ISO 13485 & MDR Integrated Toolkit?

CREATED BY EXPERTS

Advisera’s toolkits are developed by some of the most experienced auditors, trainers and consultants for the ISO 13485 standard.

EASY TO UNDERSTAND, SIMPLE TO USE

All documents are 80% pre-written. By filling in the specifics of your company, you’ll save both time and money with your ISO 13485 implementation process.

WE’RE REAL PEOPLE

Our experts will guide you through the whole process, they will tell you where to start, what the next steps are, and how to resolve any issues you may face.

WHAT MAKES ISO 13485 & MDR INTEGRATED TOOLKIT SPECIAL

80% COMPLETE – GUIDANCE FOR THE REMAINING 20%

We’ve done 80% of the work a consultant would charge you for. Anything that can be prefilled in the documents is already done, and the remaining adaptation you need to do is clearly marked with comments and instructions.

STEP-BY-STEP GUIDANCE FOR YOUR IMPLEMENTATION

The toolkit documents are organized to guide you on your implementation path. They’re structured in clearly numbered folders, so that you know where to start, and – after each document is completed – where to go next.

PLACEHOLDERS GUIDE YOU WHERE EDITING IS NEEDED

Simply move through the documents, filling in the specifics for your company as instructed. Our experts have even added some instructions on what to enter, to help you move through the implementation as efficiently as possible.

ADDITIONAL INSTRUCTIONS FOR MORE SPECIFIC TASKS

Completing some parts of a document might be a challenge for you if you’ve never done this before. In these cases, we’ve added detailed instructions and, where needed, links to articles that will help you understand and complete these sections.

FULLY CUSTOMIZABLE DOCUMENTS

Most companies have a specific design and structure for their official documents. There’s header information, confidentiality level, even prescribed graphic design and fonts. All of our documents are fully customizable, so that you can make them look just the way they should.

ALL THE SUPPORT YOU NEED

ISO 13485 certification is much more than just documentation. The implementation of the standard needs to be appropriate to your company, and you need to deal with your employees, your management, and your existing processes in an appropriate way.

This is why our experts are on hand with live online support to answer any difficult questions – we can set up a call via Skype, over the telephone, or through any other method convenient for you; or, we can answer your questions via email – whatever suits you best.

ISO 13485 & MDR Integrated Documentation Toolkit - 13485Academy ISO 13485 & MDR Integrated Documentation Toolkit - 13485Academy

997 EUR
Buy now DOWNLOAD FREE DEMO

Sold in 107 countries

payment cards
security key image 100% secure online billing
AES-128bit SSL safe

TOOLKIT FEATURES

ISO 13485 & MDR Integrated Documentation Toolkit - 13485Academy

OVERVIEW

  • Compliant with
    ISO 13485:2016
    ISO 14971:2019
    EU MDR 2017/745
  • Number of documents
    101
  • Format
    Microsoft Office 2007 / 2008 / 2010 / 2011 / 2013 / 2016 (can be easily converted into Google Docs and Google Sheets)
  • Free upgrades
    Within 12 months of purchase
  • Optimized for
    Small and medium-sized organizations
ISO 13485 & MDR Integrated Documentation Toolkit - 13485Academy

DOCUMENTATION

  • Documentation fully editable?
    Yes. You can adapt any document by entering specific information for your organization.
  • Acceptable for ISO 13485 certification audit?
    All documents required by ISO 13485:2016 are included, as well as ISO 14971 and EU MDR documents, plus other optional policies and procedures that are most commonly used.
  • Guidelines
    An average of 20 comments per template guiding you on what to fill out.
  • Delivery
    Documents are available immediately after payment.
ISO 13485 & MDR Integrated Documentation Toolkit - 13485Academy

EXPERT SUPPORT

  • Project kick-off
    initial meeting with an expert to help you start your project
  • Implementation support
    series of live one-on-one online meetings with an expert
  • Document review
    expert review of your completed documents
  • Pre-audit check
    1 hour call where we can check the most important items that the certification auditor will be looking for (available only in toolkit with extended support and Power Toolkit)
  • Unlimited email support

TOOLKIT DOCUMENTS

Look at EVERY template in the ISO 13485 & MDR Documentation Toolkit – for free! – before making a purchase decision.

Procedure for Risk Management (according to ISO 14971)
Preview
Risk Management Plan
Preview
Risk Management File
Preview
Procedure for FMEA Risk Assessment
Preview
FMEA Risk Assessment Record
Preview
Risk Management Review
Preview
Quality Policy
Preview
Quality Objectives and Realization Plan
Preview
Quality Manual
Preview
Procedure for Document and Record Control
Preview
List of Internal Documents
Preview
List of External Documents
Preview
List of Types of Records
Preview
Registry of Records for Retention/Central Archive
Preview
Procedure for Human Resources
Preview
Training Program
Preview
Training Record
Preview
Record of Attendance
Preview
Procedure for Infrastructure and Work Environment
Preview
Record of Infrastructure Maintenance
Preview
Sales Procedure
Preview
Product Requirement Review Record
Preview
Procedure for Customer Communication, Feedback and Complaints
Preview
Customer Feedback Report
Preview
Registry of Customer Complaints
Preview
Registry of Reports to the Authorities
Preview
Procedure for Design and Development
Preview
Design and Development File
Preview
Project Plan and Review
Preview
Change Review Record
Preview
Design Review Minutes
Preview
Design and Development Verification and Validation Plans
Preview
Verification Report
Preview
Validation Report
Preview
Design and Development Transfer Record
Preview
Procedure for Purchasing and Evaluation of Suppliers
Preview
Checklist for Evaluation of Suppliers
Preview
List of Approved Suppliers
Preview
Registry of Complaints about Suppliers
Preview
Request and Order for Purchasing
Preview
Purchasing Verification Record
Preview
Quality Agreement for Critical Supplier
Preview
Quality Agreement for Subcontractor
Preview
Procedure for Production and Service Provision
Preview
Product Specification
Preview
Record of Product/Service Conformance
Preview
Quality Plan
Preview
Notification to a Customer about Changes on Property
Preview
Record of Production Process Validation
Preview
Record of Medical Device Installation
Preview
Record of Servicing Activities
Preview
Record for Sterilization
Preview
Procedure for EtO Sterilization
Preview
Procedure for Steam Sterilization
Preview
Procedure for Dry Heat Sterilization
Preview
Procedure for Ionizing Radiation Sterilization
Preview
Procedure for Filtration Sterilization
Preview
Procedure for Documentation and Validation of Computer Software
Preview
Record of Software Validation
Preview
Warehousing Procedure
Preview
Record for Temperature and Humidity Control
Preview
Pest Control Record
Preview
Non-Conforming Product Record
Preview
Registry of Non-Conformities
Preview
Registry of Recalled / Withdrawn Products
Preview
Procedure for Control of Non-Conforming Products
Preview
Procedure for Adverse Event Investigation and Reporting
Preview
Adverse Event Report
Preview
Procedure for Equipment Maintenance and Measurement Equipment
Preview
List of Equipment
Preview
Plan for Preventive Maintenance of Equipment
Preview
Maintenance and Calibration Record
Preview
Procedure for Internal Audit
Preview
Internal Audit Program
Preview
Internal Audit Report
Preview
Internal Audit Plan
Preview
Internal Audit Checklist
Preview
Procedure for Corrective and Preventive Action
Preview
Corrective/Preventive Action Request
Preview
Registry and Status of Corrective and Preventive Actions
Preview
Procedure for Data Analysis
Preview
Data Analysis Report
Preview
Procedure for Management Review
Preview
Matrix of Key Performance Indicators
Preview
Management Review Minutes
Preview
Procedure for Clinical Evaluation
Preview
Clinical Evaluation Plan
Preview
Clinical Evaluation Report
Preview
Literature Research Protocol
Preview
Declaration of Interest
Preview
Procedure for Post-Market Surveillance System
Preview
Post-Market Surveillance Plan
Preview
Post-Market Surveillance Report
Preview
Periodic Safety Update Report
Preview
Post-Market Clinical Follow-up Plan
Preview
Technical File Procedure
Preview
Technical File Template
Preview
Technical Documentation Checklist
Preview
List of UDI-DI
Preview
Summary of Safety and Clinical Performance
Preview

EXPERT SUPPORT

How does EXPERT SUPPORT work?

1

Live expert support

Our ISO 13485 expert will meet with you regularly – she will tell you where to start, what the next steps are, and how to resolve any issues you may face. You can meet via Skype, over the telephone, or through any other means at your convenience.

2

Unlimited email support

Reach out to us at any time during your implementation project with unlimited email support, and have your questions answered within 24 hours by our experts.

3

Expert review of a document

Once you complete your documents, let our experts review them – they’ll provide you with feedback and indicate what needs to be improved.

Here’s your ISO 13485 expert

Kristina Zvonar Brkic has worked as a consultant and lead auditor for ISO 13485, ISO 9001, ISO 14971 and ISO 22716 for more than 10 years. She has also worked as an auditor and assessor for medical devices under MDD for 7 years, and currently MDR.
The portfolio of medical devices for which she has approval are plastic products with measuring function, various creams and gels, different systems for wound care, disinfectants, dental materials, different catheters, panels for operating rooms and clean rooms, accessories and kits for performing surgical procedures of non-woven materials, medical gases, and various dental materials.

Kristina Zvonar Brkic

Kristina Zvonar Brkic

Lead ISO 13485 expert

Schedule your consultation
Want to see what the documents look like?

Schedule a free presentation, and our representative will show you any document you're interested in.

NEED MORE SUPPORT?

TOOLKIT WITH EXPERT SUPPORT

101 document templates compliant with ISO 13485:2016, ISO 14971:2019 and EU MDR 2017/745

10 questions via email per month

One-on-one support with an ISO 13485 expert
1 hour

Expert review:
1 completed document

997 EUR
ORDER NOW

TOOLKIT WITH EXTENDED SUPPORT

101 document templates compliant with ISO 13485:2016, ISO 14971:2019 and EU MDR 2017/745

Unlimited email support

One-on-one support with an ISO 13485 expert
5 hours

Expert review:
5 completed documents

Pre-audit check (1 hour call where we can check the most important items the certification auditor will be looking for)

1497 EUR
ORDER NOW

POWER TOOLKIT

101 document templates compliant with ISO 13485:2016, ISO 14971:2019 and EU MDR 2017/745

Unlimited email support

One-on-one support with an ISO 13485 expert
15 hours

Expert review:
15 completed documents

Pre-audit check (1 hour call where we can check the most important items the certification auditor will be looking for)

2497 EUR
ORDER NOW

FAQS: BUYING ISO 13485 & EU MDR DOCUMENTATION TOOLKIT

When and how will I get the toolkit?

Immediately after the transaction is processed, you will receive an email with a download link. It could not be quicker or simpler.

What kinds of payment can you accept?

We take all major credit cards, PayPal payment, and we can accept a wire transfer from your bank account.

Are my payment details secure?

We proudly use Secure Socket Layer (SSL) technology, which is the industry standard. This technology encrypts your credit card information, keeping it secure, and sends it directly to the payment processor. We never store – or even see – your payment information.

Which currencies can I use?

We gladly accept more than 50 commonly used currencies, including the US Dollar, the Euro, the British Pound, and the Swiss Franc.

I’m still not sure if this toolkit is right for my business. Can I try it out before I decide to buy?

Please do! Click on the “DOWNLOAD FREE TOOLKIT DEMO” button and enter your name and your email address. You can instantly access a free preview of each document template, helping you make up your mind. This is a great chance to see how each document looks, and how easy they are to complete.

Is the toolkit compliant with the newest changes in the ISO 13485, ISO 14971 and EU MDR?

Yes. Also, you are entitled to receive free updates of those toolkits for one year after your purchase date.

Who is Advisera?

Advisera Expert Solutions Ltd is a company specialized in providing online support for ISO implementation. In the last 10 years it covers all the major ISO standards, and is selling its products in more than 100 countries worldwide. Read more here.

Want to see what the documents look like?

Schedule a free presentation, and our representative will show you any document you're interested in.

WHAT OUR CUSTOMERS
SAY ABOUT US

The toolkit was extremely helpful in that the procedures were easy to follow, had a good structure and allowed me to make adjustments to tailor them to my needs. I didn’t have to start from scratch or spend hours searching the web for templates. The procedures integrated ISO 13485 and the MDR with ease.

Rehan Electronics Ltd.

RJ Blake

The toolkit provides good guidelines to QMS development.

Koln 3D Technology (Medical) Limited

Dr. Francis Wong

Our clients

ISO 13485 & MDR Integrated Documentation Toolkit - 13485Academy
ISO 13485 & MDR Integrated Documentation Toolkit - 13485Academy
ISO 13485 & MDR Integrated Documentation Toolkit - 13485Academy
ISO 13485 & MDR Integrated Documentation Toolkit - 13485Academy
ISO 13485 & MDR Integrated Documentation Toolkit - 13485Academy
ISO 13485 & MDR Integrated Documentation Toolkit - 13485Academy
ISO 13485 & MDR Integrated Documentation Toolkit - 13485Academy ISO 13485 & MDR Integrated Documentation Toolkit - 13485Academy

997 EUR
BUY NOW

SOLD IN 107 COUNTRIES

payment cards
security key image 100% secure online billing
AES-128bit SSL safe