Get 4 FREE months of Conformio to implement ISO 27001
Implement ISO 13485, ISO 14971 and EU MDR without using a consultant.
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.
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.
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
CUSTOMERS FROM 107 COUNTRIES
100% secure online billing
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
100% secure online billingWe’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.
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.
