Medical Device Training

Medical Device Training

ISO 13485:2016

Now replaces the previous version of the standard, EN ISO 13485:2012, in the EU Official Journal, with the date of cessation of 31 March 2019.

ISO 13485:2016 Introduction

We cover various clauses of the medical device standard and how to manage your quality system to achieve compliance with the standard.

ISO 13485:2016 Clause by Clause

This training provides an in depth review of ISO 13485:2016. We breakdown the clauses to provide an understand the implications behind the quality management requirements for medical device manufacturers.

ISO 13485:2016 Transition & Auditor Refresher

We identify the key changes in ISO 13485:2016 and refresh your auditing skills to align with the new standard.

Medical Device Risk Management ISO 13485:2016

We review effective management of your medical device risks and highlight key risk management processes based on ISO 14971.

Medical Devices Directive (MDD) to Medical Devices Regulation (MDR) Transition training

The Medical Devices Regulation (MDR) has replaced the Medical Devices Directive (93/42/EEC) as the legislation detailing the requirements which manufacturers have to meet to place medical devices on the market in the European Union, including Australian and various Asian markets.

TGA

TGA regulatory training specializing in pre-market to post-market medical device requirements

Medical Device Single Audit Program (MDSAP)

An international program whereby Auditing Organizations (AO) can conduct a single audit of a medical device manufacturer that would be accepted by multiple regulators to address QMS/GMP requirements (Australia TGA, Brazilian ANVISA, Health Canada, US FDA and Japanese MHLW).

For those holding CMDCAS certification, Health Canada has announced that as of 1 January 2019, they will terminate their current CMDCAS program and only accept MDSAP certificates. Manufacturers with products on the market in Canada cannot wait until 29 February 2019 to transition to the ISO 13485:2016 certificate. Failure to meet the 1 January 2019 date for transition to a MDSAP certificate may mean your products will not be licensed in Canada.

Process Validation for Medical Device Manufacturers

This training is designed for manufacturers wanting to increase awareness of quality requirements regarding validation and the nature of special processes.  We cover principles of validation and methods of installation, operations and process qualification.