SPRING DISCOUNT
Get
30%
off on toolkits, course exams, and Conformio yearly plans.
Limited-time offer – ends
April 25, 2024
Use promo code:
SPRING30
ISO 13485
Advisera Home
ISO 27001
NIS 2
ISO 9001
EU GDPR
ISO 14001
EU MDR
ISO 45001
ISO 13485
ISO 17025
IATF 16949
ISO 22301
AS9100
ISO 20000
ISO in General
Contact Us
Log in
Conformio
Training
Community
Partner Panel
Experta
Implement & Learn
Implementation Products
Conformio
ISO 27001 Compliance Software
Built by top industry experts to automate your compliance and lower overhead.
Learn more
ISO 13485 Documentation Toolkits
All Policies, Procedures, and Records
Our toolkits supply you with all of the documents required for ISO certification.
View all
Learning Products
ISO 13485 Training
Accredited Online Training by Top Experts
Our course and webinar library will help you gain the knowledge that you need for your certification.
View All
Conformio
Documentation Toolkits
Training
Resources
Resources
By Type
Articles
Webinars
Courses
White Papers
Templates & Tools
View All
Where to Start
ISO 27001
NIS 2
ISO 9001
EU GDPR
ISO 14001
EU MDR
ISO 45001
ISO 13485
ISO 17025
IATF 16949
ISO 22301
AS9100
ISO 20000
ISO in General
New
AI Tool
Experta: AI-Powered Knowledge Base
Try now
Other
Live Consultations
Consultant Directory
Community
Resources
For Consultants
About Us
ISO 13485 Expert
Kristina Zvonar Brkic
Lead ISO 13485 expert
About Advisera
Contact Us
Get Started
CUSTOMERS AROUND THE WORLD TRUST OUR PRODUCTS
Read their success stories
"You have helped us immensely over these last few months."
Stephan Lesher
Director of Information Technology, Chief Security Officer at Alpha Systems
"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
Export manager, SVENSKA DENTORAMA AB.
"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
Quality Coordinator, Titronics
"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
Quality Manager, Rehan Electronics Ltd.
"The toolkit provides good guidelines to QMS development."
Dr. Francis Wong
Koln 3D Technology (Medical) Limited
"It helps to stay focused on the key steps and offers a structure for roll out of the project."
Ludo Claes
LC Company
"Your effort in building a self implementation toolkit is fantabulous."
Parvez Hamza
Senior Risk & Compliance Analyst, Gasco
"Helped me a lot. Very useful and profesional documents. Warm regards from Latin America."
Elder Guerra
Aseguradora Fidelis, S.A.
"Your documentation has really been a huge help. Our stage 2 audit is on Monday, and you have really helped to plug areas that we were lacking. The content you have is what impressed me the most. While we had all the docs that I purchased from you, yours just felt much more complete."
Timothy Cohen
System Administrator at Alpha Systems
"This information has guided me in certain ways that I thought I was doing proper, and discovered there were easier ways of accomplishing ISO with the proper information in hand."
Tim Johns
NGHS
"Toolkit gives a great base for own documents. It also teaches some really helpful best practices (document structures, helpful comments, etc.)."
Christoph Thiel
prof.
"The toolkit has provided me with some great starting places so I don't have to create various documents from scratch or spend time searching the web for examples and templates."
Christy Bentivoglio
"Provides a structured how-to guide how improve QMS documentation."
Andre van Hees
AirTies
"Clear, precise, concrete."
Emir Ramic
Head of Information Technology
"Better know which documents are essentials. And that documents are consistent and clean."
Ziemowit Borowski
Poland
"Your articles and templates gives excellent oversight of the requirements and help to organize the process."
Atle Dalsbø
LocalHost AS
"The documents are well laid out and with our company’s standard formatting they are just falling into place."
Thomas Green
CBCP
"Managed the documentation with ease."
Nisar Khan
Kuwait International Bank
"When I opened the toolkit I was desperate to implement the system and I found myself moving quick because the toolkit is rich in useful documentation. It's reducing me time of thinking, verifying searching for information and typing. And it also give me an opportunity to see how other experts develop their systems. It doesn't have a few site specific documents that I need but it's still fine."
Susanne Wesner
Stepitup