Freyr’s toolkit for medical devices, is a one-stop solution for ISO 13485:2016 compliance
Our toolkit is curated by a dedicated team of MDV consultants provides comprehensive solutions to meet the mandatory documentation requirements as per ISO 13485:2016, ensuring you have all the necessary tools.
Freyr ISO 13485:2016 Toolkit is Tailored to Your Needs
If you are a manufacturer looking to launch your medical devices or if you are planning to complete your ISO 13485:2016 compliance process, our toolkit is tailored precisely to cater to all your needs. The ISO 13485:2016 toolkit combines the documentation templates, SOPs and expert support to streamline your workload and ensure you meet all the guidelines and regulations with ease.
Key Features
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End to end Solution
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Customisable Toolkit
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Includes 90+ Templates and Procedures
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Cost Efficient
Mandatory Standard Operating Procedures
Mandatory Standard Operating Procedures
The mandatory standard operating procedure contains all the necessary SOPs and templates that you need to ensure QMS Compliance. You can choose the SOPs and Templates as per your need.
Comprehensive Toolkit
Comprehensive Toolkit
Our comprehensive toolkit is a one stop solution that provides a complete package to help you become ISO 13485:2016 compliant, and to support you throughout the compliance process.
QMS Consultation for your Region.
QMS Consultation for your Region.
Avail QMS consultation customized to your company’s needs. Our team of QMS experts will curate a tailored made solution as per the requirement and the product(s) in scope.
Freyr QMS Experts for Medical Devices
Freyr’s ISO 13485:2016 expert team consists of highly trained QA specialists with over 20 years of experience in QMS strategizing, documentation, gap assessment, and ISO 13485:2016 audit support.
As the Global leader in life sciences and regulatory affairs, Freyr has extensive experience in managing QMS and regulatory requirements for medical devices, ensuring ISO 13485:2016 compliance. Our experts understand your organization’s needs and are dedicated to making your medical device ISO 13485:2016 compliant.
Why Freyr?
