ISO 13485 DOCUMENTATION TOOLKIT
Implement ISO 13485 yourself, and do it easily and efficiently with our Documentation Toolkit.
75 document templates – unlimited access to all documents required for ISO 13485 certification, plus commonly used non-mandatory documents
Document templates come in correct framework ready to implement
Email support and online chat support
Expert review of a document
Fully optimized for
small and medium-sized companies
What is ISO 13485
ISO 13485 is the medical device industry’s most widely used international standard for quality management. Issued by the International Organization for Standardization (ISO), the ISO 13485 standard is an effective solution to meet the comprehensive requirements for a Quality Management System in the medical device industry.
Commitment to safety & quality
Adopting ISO 13485 provides a practical foundation for manufacturers to address the EU Medical Device Directive (MDD), the EU Medical Device Regulation (MDR), and other regulations, as well as demonstrating a commitment to the safety and quality of medical devices.
A Systematic Approach
A quality management system not only creates effective communication channels to articulate deficiencies, but it also provides systematic methods for improving processes through six sigma and lean techniques. Whether it’s through quality auditing or corrective action requests, systematic improvement is a benefit of ISO 13485 certification.
Less
Waste
Waste reduction in all parts of the production process is a direct result of building an organization to conform to ISO standards. Identification and removal of overproduction, waiting, excess inventory, defects, and scrap are among the benefits of quality management system deployment.
Higher
Prestige
Meeting ISO requirements enable companies in the medical device industry to better market their products and services. When they become certified, they have met an objective standard of excellence that enhances their competitive advantage in the marketplace.
EASY-TO-USE COMPLIANCE OPERATIONS SOFTWARE, BUILT BESPOKE FOR YOUR BUSINESS
I Comply ISO offers uncomplicated bespoke compliance management systems developed to establish a culture of continual improvement and ensure compliance with your compliance obligations.
We make standards & regulations easy to understand and simple to implement through I Comply.
Customised documentation to suit your business so you can implement ISO standards in the correct frameworks. No more guessing what's happening on site.
Get visibility of your operation with full quality control.
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FAQS: BUYING THE ISO 13485 PACK
How will I receive the documentation?
Immediately after the transaction is processed, you will receive an email with a download link. It could not be quicker or simpler.
Which methods of payment do you accept?
We take all major credit cards, PayPal payment, and we can accept a wire transfer from your bank account.
Are my credit card details going to be safe?
Absolutely. We use Secure Socket Layer (SSL) technology, the industry standard and among the most secure for online transactions. All of your credit card information is encrypted and sent directly to the payment processor – we do not see or store your card information.
Is the toolkit compliant with the newest changes in the ISO 13485 standard?
Yes. We actively update our toolkits to ensure they are up to date with the latest standards