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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

  • 117 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

1097 EUR
PROCEED TO CHECKOUT

CUSTOMERS FROM 107 COUNTRIES

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TOOLKIT DOCUMENTS

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

ISO 13485 & EU MDR INTEGRATED TOOLKIT:

RIGHT FOR YOUR BUSINESS?

ISO 13485 & MDR Integrated Documentation Toolkit - 13485Academy

CREATED BY EXPERTS

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

ISO 13485 & MDR Integrated Documentation Toolkit - 13485Academy

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.

ISO 13485 & MDR Integrated Documentation Toolkit - 13485Academy

Built for Small Businesses

We have built the toolkit to help small businesses minimize the time and cost of implementation. Our easy-to-use toolkit will help you implement your medical device quality management policies and set yourself up for ISO 13485 & ISO 14971 certification and EU MDR compliance.

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.

1097 EUR
Buy now DOWNLOAD FREE DEMO

Sold in 107 countries

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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
Want to see what the documents look like?

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

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

ISO 13485 & MDR INTEGRATED TOOLKIT OPTIONS

Toolkit with expert support
1097 EUR
Toolkit with extended support
1597 EUR
Power toolkit
2597 EUR
117 document templates compliant with ISO 13485:2016, ISO 14971:2019 and EU MDR 2017/745
Email support
10 questions per month
Unlimited
Unlimited
One-on-one support with an ISO 13485 expert
1 hour
5 hours
15 hours
Expert review (completed documents)
1 document
5 documents
15 documents
Pre-audit check

1 hour call where we can check the most important items the certification auditor will be looking for

1097 EUR
117 document templates compliant with ISO 13485:2016, ISO 14971:2019 and EU MDR 2017/745
Email support
10 questions per month
One-on-one support with an ISO 13485 expert
1 hour
Expert review (completed documents)
1 document
Pre-audit check

1 hour call where we can check the most important items the certification auditor will be looking for

1597 EUR
117 document templates compliant with ISO 13485:2016, ISO 14971:2019 and EU MDR 2017/745
Email support
Unlimited
One-on-one support with an ISO 13485 expert
5 hours
Expert review (completed documents)
5 documents
Pre-audit check

1 hour call where we can check the most important items the certification auditor will be looking for

2597 EUR
117 document templates compliant with ISO 13485:2016, ISO 14971:2019 and EU MDR 2017/745
Email support
Unlimited
One-on-one support with an ISO 13485 expert
15 hours
Expert review (completed documents)
15 documents
Pre-audit check

1 hour call where we can check the most important items the certification auditor will be looking for

FAQS: BUYING ISO 13485 & EU MDR INTEGRATED 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 template has made it easier to know what information is needed. I have found Advisera's 13485Academy very helpful in providing information for helping me understand what is needed to transition our FDA 21 CFR, Part 820 to also be compliant with ISO 13485:2016. The EU MDR Checklist of Mandatory Documents has been a great guide for getting all documents ready to send in for EU certification. A lot of great information and guidance can be found at 13485Academy.

Titronics

Catherine Nelson

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