All documents listed below are available from the South African Department of Health. Electromedical devices fall under the scope of the Hazardous Substances Act, No...
Resource Library for Medical Device Professionals
85 total results. Show all resources.
Australia
Medical Device Registration in Australia & New Zealand
This white paper answers your biggest questions about how to register your medical device or IVD in Australia or New Zealand.
6 pages
Nov 12, 2014
Australia
Transitioning to Medical Device Single Audit Program (MDSAP) Compliance
In this white paper, we discuss the steps you should follow to achieve MDSAP certification.
8 pages
Jan 15, 2018
Brazil
Brazil QMS Requirements For Medical Device Manufacturers
Thinking about selling your medical device in Brazil? This Brazillian market is complex but the sales potential is worth the effort.
9 pages
Apr 6, 2015
Brazil
Medical Device Registration Process in Brazil
Interested in selling your medical device in Brazil? Brazil's device registration process is well established, but very complex. It's important to understand the process upfront to avoid delays down the road.
11 pages
Apr 12, 2017
Brazil
Overview of the IVD Regulatory Landscape in Brazil
In this white paper, learn about recent changes to the regulatory process for IVDs in Brazil.
7 pages
Dec 14, 2016
Brazil
Transitioning to Medical Device Single Audit Program (MDSAP) Compliance
In this white paper, we discuss the steps you should follow to achieve MDSAP certification.
8 pages
Jan 15, 2018
Canada
Preparing a Canadian MDL Application
This white paper includes a detailed comparison of Health Canada's Medical Device License application and a US FDA 510(k).
17 pages
Oct 7, 2015
Canada
Achieving QMS Compliance for Canada Beyond ISO 13485
An in-depth look at Quality Management System (QMS) regulations as they apply in Canada for obtaining a Medical Device License (MDL).
6 pages
Sep 16, 2016
Canada
Transitioning to Medical Device Single Audit Program (MDSAP) Compliance
In this white paper, we discuss the steps you should follow to achieve MDSAP certification.
8 pages
Jan 15, 2018
China
China CFDA Medical Device Registration Requirements
This white paper discusses how to register your medical device with the CFDA in China.
8 pages
Aug 11, 2017
Europe
Understanding Europe's New IVDR 2017/746
Europe's new IVDR 2017/746 will bring significant regulatory changes for IVD manufacturers selling in Europe.
16 pages
Oct 31, 2016
Europe
How ISO 13485:2016 Impacts Medical Device Companies
ISO 13485:2016 provides an international QMS standard and introduces notable changes, particularly in the area of risk management.
16 pages
Feb 1, 2016
Europe | Medical Devices
Understanding Europe's New Medical Device Regulation - MDR 2017/745
Europe's new Medical Device Regulation 2017/745 (MDR) will bring substantial changes to the medical device industry. How will this affect your company?
28 pages
Jul 5, 2016
Europe
Regulations for Companion Diagnostics in the US and EU
In this paper, we answer your biggest questions about the obstacles and opportunities of marketing companion diagnostics in the US and Europe.
5 pages
Nov 11, 2016
Europe
Implementing a Medical Device Post-Market Surveillance Program
Post-market surveillance is a regulatory requirement the US and Europe and helps you ensure your device's safety and effectiveness.
6 pages
Mar 14, 2016
Europe | Medical Devices
ISO 14971 Medical Device and IVD Risk/Benefit Analysis
This white paper explores risk management procedures and protocols required to comply with ISO 14971.
9 pages
Jun 17, 2016
Europe
ISO 13485:2016 and the new Risk-based Approach
This white paper provides an overview of new risk requirements and considerations for devices companies under the new standard.
12 pages
Sep 6, 2017
Europe
CE Marking Conformity Assessment for Medical Devices
Your conformity assessment route has implications for your business you might not expect. How do you know which route is best for you?
6 pages
Mar 29, 2016
Europe
Preparing a European CE Technical File for a Medical Device
Take a deep dive into the key elements of an EU Technical File, including preparation, formatting, and common elements.
8 pages
Nov 24, 2015
Europe
EU Medical Device Vigilance Reporting
Vigilance reporting is confusing for many manufacturers in Europe but it is critical to comply with vigilance requirements. In this whitepaper, we'll answer your biggest questions about vigilance reporting.
7 pages
Jun 19, 2014
Europe
Classification Borderline: What Constitutes a Medical Device?
How do you classify a product that fits the definition of two or more product types? This paper explains borderline classification in the EU.
5 pages
Feb 25, 2016
Europe
European Clinical Investigation of Medical Devices
How to avoid errors in communication, planning, conduct, evaluation, or reporting of clinical studies that could delay your market access in Europe.
10 pages
Jul 22, 2014
Europe
Medical Device Labeling, Standards and Symbols
Learn about the standards, requirements, and benefits of medical device labeling and symbols. Includes a list of common symbols and meanings.
7 pages
Sep 28, 2016
Europe
Preparing to Change your European Notified Body
This white paper discusses how to find a new European Notified Body for MDR compliance.
9 pages
Jan 30, 2018
Europe
Post-Market Clinical Follow-up (PMCF) Studies in Europe
This white paper discusses PMCF study requirements in Europe and relevant changes under the new MDR.
7 pages
Sep 6, 2017
Europe
Overview of ISO 11135:2014 and Medical Device Sterilization
ISO 11135:2014 is recognized as the international standard for process management and validation requirements of Ethylene Oxide (EO) sterilization.
12 pages
Sep 29, 2016
Europe
Clinical Investigational Studies in Europe
This white paper discusses the European clinical investigation requirements and how to know when you're ready for this important step.
5 pages
Dec 12, 2016
Europe | In-Vitro Diagnostic Devices, | Medical Devices
Unannounced Notified Body Audits & Your Critical Suppliers
In this white paper, we discuss audit and assessment duties for Notified Bodies in Europe, including performing unannounced audits.
9 pages
Nov 12, 2014
Europe
Introduction to CE Marking for Medical Devices
CE Marking is required to sell your medical device in Europe. Get an overview of the process, requirements, regulations, and more.
8 pages
Feb 11, 2013
Europe | Medical Devices
The Role of Eudamed under the MDR and IVDR
In this white paper, you will learn about the role of Eudamed under the new MDR and IVDR.
14 pages
Jul 31, 2018
Europe
How to Select and Change a Notified Body in Europe
This white paper discusses key points of the Notified Body search, including how to find a new Notified Body well-suited to your company.
5 pages
Mar 13, 2014
Europe
ISO 10993-1 and Biocompatibility for Medical Devices
If you are marketing a device in Europe, the US, or even beyond, the ISO 10993 series is your guide to biocompatibility testing requirements.
16 pages
Apr 22, 2016
Europe | Medical Devices
Conformity Assessment Routes under the EU Medical Devices Regulation (MDR 2017/745)
Download this white paper for an in-depth look at conformity assessment options under the new MDR.
9 pages
Aug 6, 2018
Europe
Medical Device Clinical Evaluation Reports for CE Marking
The clinical evaluation report (CER) is a key component of Technical File and the CE Marking process so it's important to get it right.