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ISO 13485 resources and downloads.

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Webinar: Ensure patient safety with medical device certification

Get expert insight on ISO 13485, MDSAP, the audit process and ultimately how certification can give you and your stakeholders greater confidence in your products’ quality and compliance.

Webinar
Medical
ISO 13485

Case Study: Oceanz

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

Case Study
ISO 13485

Medical Device Single Audit Program

Download the MDSAP factsheet to learn about the benefits of the program and how your organisation can meet compliance.

Datasheet
Medical
ISO 13485

5 Ways Virtual Classroom Training can improve the learning experience

In this article, gain insight from our voice on online training, Paul Smith, who makes the case for Virtual Classroom training.

Article
AS9100
IATF 16949
ISO 22301

Management Systems Training Price List 2021

Find the right course for your industry and development needs with our updated training listing.

Brochure
Training Material
Training
Management Systems

Penlon ISO 13485 Transition Case Study

Discover the steps that Penlon took before pursuing ISO 13485:2016 certification, and their key learnings from their transition process.

Case Study
ISO 13485
Medical
Healthcare & Medical

ISO 13485:2016 Factsheet

Download the factsheet to understand the importance of ISO 13845, the benefits and how your organisation can achieve compliance.

Datasheet
ISO 13485
Medical
Healthcare & Medical

ISO 13485 Frequently Asked Questions

LR’s technical experts share their insight into ISO 13485 for medical device manufacturers planning to implement the international quality management system standard.

Brochure
ISO 13485
Medical
Healthcare & Medical

ISO 13485:2016 Overview Guide

Want to achieve ISO 13485:2016 certification but don’t know where to start? Download this guide for an overview of the requirements and practical guidance.

Brochure
ISO 13485
Healthcare & Medical

ISO 13485:2016 & MDSAP Gap Analysis Factsheet

Download our factsheet to learn how a gap analysis can help you focus on high risk or weak areas of your medical device QMS ahead of your formal assessment visit.

Datasheet
ISO 13485
Medical
Healthcare & Medical
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