Implement ISO 13485, ISO 14971 and EU MDR without using a consultant.
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.
We will answer your questions within 1 business day. You can send up to 10 questions per month.
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.
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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.
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RISKS AND OPPORTUNITIES
POLICY AND MANUAL
DOCUMENT CONTROL
HUMAN RESOURCES
INFRASTRUCTURE AND WORK ENVIRONMENT
SALES PROCEDURE
CUSTOMER COMPLAINTS AND FEEDBACK
DESIGN & DEVELOPMENT
PURCHASING PROCEDURE
PRODUCTION & SERVICE PROVISION
STERILIZATION
SOFTWARE VALIDATION
WAREHOUSING PROCEDURE
NONCONFORMITIES
ADVERSE EVENT INVESTIGATION
EQUIPMENT MAINTENANCE
INTERNAL AUDIT
CORRECTIVE AND PREVENTIVE ACTIONS
DATA ANALYSIS
MANAGEMENT REVIEW
CLINICAL EVALUATION
POST-MARKET SURVEILLANCE
TECHNICAL FILE
Advisera’s toolkits are developed by some of the most experienced auditors, trainers and consultants for the ISO 13485 standard.
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 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.
Sold in 107 countries
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.
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.
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.
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.
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.
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.
Schedule a free presentation, and our representative will show you any document you're interested in.
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.
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.
Once you complete your documents, let our experts review them – they’ll provide you with feedback and indicate what needs to be improved.
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.
1 hour call where we can check the most important items the certification auditor will be looking for
1 hour call where we can check the most important items the certification auditor will be looking for
1 hour call where we can check the most important items the certification auditor will be looking for
1 hour call where we can check the most important items the certification auditor will be looking for
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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.
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Schedule a free presentation, and our representative will show you any document you're interested in.
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.
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.
RJ Blake
The toolkit provides good guidelines to QMS development.
Dr. Francis Wong
How can ISO 13485 help with MDR compliance?
What is EU MDR?
How can ISO 13485 help manufacturing companies?
As a medical device manufacturer, if you are implementing an ISO 13485:2016 Quality Management System (QMS), you may wonder how the new European Union Medical Device Regulations (EU MDR) affect you, and how your QMS can help with meeting these new requirements. This article will help to explain the relationship between these two requirements.
It is important to note the difference between these two frameworks. The EU MDR is a regulation released by the European Union that dictates what needs to be done by a company that wants to manufacture or import medical devices into the European Union. This regulation includes information on how medical devices need to be marked and certified, along with updates on what information needs to be submitted to the updated Eudamed database, which stores the regulatory information for each medical device. In short, the EU MDR tells you what you need to do to produce medical devices for the European Union market.
ISO 13485, on the other hand, is an internationally recognized standard for creating a QMS for medical device companies anywhere in the world. ISO 13485 requirements can be used by any organization that needs to demonstrate that it produces medical devices and provides related services that consistently meet customer and regulatory requirements. Where the EU MDR applies to companies that sell medical devices in the European Union, ISO 13485 applies to any company throughout the world.
Throughout the EU MDR regulation it is stated that manufacturers need to have a Quality Management System in place. This QMS needs to ensure that all medical devices are covered by the QMS rules, that the devices are used under the appropriate QMS processes, and that a post-market surveillance system is set up and used.
This management system needs to be audited by a notified body, an organization that is designated by an EU member state to do assessments of higher-class medical devices, in order to certify the medical devices that are created using the QMS processes. In order for a medical device to be certified, and have an indicating CE mark, the company must have a QMS in place.
In article 10 of the EU MDR, the regulation states what needs to be included in a QMS at a minimum. At the very least, the QMS needs to address the aspects in the table below, which are all covered in the ISO 13485 standard. The table shows the EU MDR requirements, and the ISO 13485 clauses that meet each requirement:
The short answer is no, ISO 13485 is not mandatory for EU MDR compliance. However, the EU MDR regulation requires that you have a QMS in place, even though it does not identify ISO 13485 directly. To assist companies in understanding all of the standards that are applicable for medical devices in the EU, the EU has created a list of harmonized standards, and the ISO 13485:2016 standard is the only QMS standard referenced on this list – therefore, most companies use ISO 13485 to implement their QMS.
What is important to note is that the EU MDR regulation is not trying to replace ISO 13485 as a QMS requirements document. The EU MDR regulation includes certain processes for medical devices that need to be in place, but the ISO 13485 standard is intended to be an all-encompassing set of inter-related requirements that form the internationally recognized best practices for a company that creates medical devices. By using the ISO 13485 requirements to create your QMS, you can ensure that you have a world-class system for your medical devices, but also a system according to the approved QMS standard by the EU.
So, how does the EU MDR impact a QMS implemented using the ISO 13485 requirements? For the most part, additional records will need to be maintained to meet the EU MDR requirements. For instance, ISO 13485 requires you to maintain a medical device file (clause 4.2.3), which has a minimum list of information to include. However, for the EU MDR regulations, this documentation will need to include all of the information that is stipulated in Annex II of the EU MDR for the medical device technical file. The EU MDR also requires the additional records of post-market surveillance and clinical evaluation. However, the processes you have in place for creating, updating, and maintaining this documentation will largely remain unchanged.
So, to conclude: you need a QMS in order to be compliant with the EU MDR regulations, and, although ISO 13485 is not directly referenced in the EU MDR regulation, this is the only QMS standard listed in the EU list of harmonized standards; therefore, it is indirectly the only reasonable way to implement a QMS according to the MDR. Since ISO 13485 provides a whole system that is devoted to helping you make your quality processes better, this is an additional benefit on top of becoming MDR compliant.
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