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ISO 13485 resources and downloads.

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Anytime. Anywhere. Remote Assurance Overview Guide

From remote audits to drone inspections, our focus on innovation and adding customer value means that we are continuously developing smart solutions to serve companies’ needs all around the world.

Guideline
Inspection
Compliance & Certification
Assurance

Client Information Note: Remote Assurance

This Client Information Note gives details of our remote assurance services, when remote assurance can be used and other key factors to be aware of.

ISO 9001
ISO 14001
ISO 45001
ISO 27001

Training Calendar Apr-Sep 2020

Download our training calendar and check availability of the courses relevant to your industry and development needs. The calendar includes all classroom, eLearning and in-house options.

Brochure
Training Material
Training
Management Systems

Penlon: Quality at its core.

Find out about the steps that Penlon took before pursuing ISO 13485:2016 certification, key learnings from their transition process and tips for organisations looking to change Certification Body.

Case Study
ISO 13485
Medical
Healthcare & Medical

Oceanz: Making life-saving, medical 3D printing a reality.

ISO 13485 certification to help Oceanz champion innovation and quality in life-saving, medical 3D printing technology. Read more in our case study.

Datasheet
Case Study
ISO 13485
Medical

ISO 13485:2016 factsheet

More and more medical device manufacturers require suppliers and service providers to be certified to ISO 13485 as a pre-requisite for doing business. Learn more about how to achieve compliance.

Datasheet
ISO 13485
Medical
Healthcare & Medical

ISO 13485 overview FAQs

LR’s medical device technical experts answer frequently asked questions to support manufacturers with the transition and address the changes that the ISO 13485:2016 revision has introduced.

Brochure
ISO 13485
Medical
Healthcare & Medical

ISO 13485 overview guide

ISO 13485 certification is one of the best ways to demonstrate compliance with the various laws and regulations active in the medical devices industry. This overview guide is intended as a starting point for organisations considering to get their management system certified.

Brochure
ISO 13485
Healthcare & Medical

Implementing ISO 13485 FAQs

Experts from Lloyd's Register answer some of the most frequent questions about implementing ISO 13485 and maintaining an effective management system.

Brochure
Medical
ISO 13485
Healthcare & Medical

ISO 13485:2016 gap analysis factsheet

This gap analysis focuses on how your medical management system has addressed or plans to address the ISO 13485 requirements.

Datasheet
ISO 13485
Medical
Healthcare & Medical
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