-->

Jul 13, 2016

Aligning ISO 13485:2016 With Additional Standards and Regulations

The 2016 MedTech Intelligence Conference 
will provide a wealth of ISO information 
and CEU credit, too.


by Marci Crane

Localization Manager

MasterControl



MedTech Intelligence, a content hub for the medical device industry, provides a continuous stream of new business analysis, technological news, trend summaries, regulations, expert opinions and networking opportunities to medical device professionals. MedTech Intelligence will host the upcoming 13485:2016 conference on July 28-29, 2016 at Dentons, 1900 K Street NW, Washington D.C.

The 2016 MedTech Intelligence 13485:2016 Conference


In line with their consistent tradition of providing up-to-date content and networking opportunities, MedTech Intelligence sponsors the “MedTech Intelligence 13485:2016 Conference,” a conference designed to provide medical device, quality, regulatory, and risk management professionals with the “latest and the greatest” solutions and powerful “tips and tricks” for industry.




This article is related to the Q&A: 
FDA Medical Device Inspector Offers Insights on Inspection
To get the full details, please download your free white paper.

ISO 13485:2016 - Everything You Will Need to Know!


The conference will provide medical device professionals with the keys for opening the doors to the new and improved final version of ISO 13485: 2016. In this version of the familiar standard, new and significant changes are required in processes related to human resources, management responsibility, risk management (as well as other aspects of the quality management system), process development, supplier controls, enhanced planning, software validation, documentation requirements, and retroactive mediation for legacy products.

During the conference experts will cover the following ISO 13485: 2016 topics:

  • What changes are taking place?
  • EU MDR/IVDR – what we know and can expect
  • MDSAP
  • ISO 13485:2016
  • ISO 9001:2015
  • Evolution and implementation timelines
  • Implications for companies

Experts will also compare and contrast the 2016 version of the ISO 13485 standards with former versions. Additional topics related to ISO 13485 include:

  • QSR
  • 13485:2003
  • 13485:2016
  • Emphasis on Risk
  • Life cycle approach
  • Key provisions

Putting Together the Puzzle of Complete Compliance


Many quality and regulatory professionals who work within the medical device industry have done their best to stay apprised of the latest ISO 13485 compliance methodologies. ISO 13485 tends to be the star of the show! However, as every medical device professional knows, there are many additional regulations and standards beyond ISO 13485 to which s/he must conform. The coordination of these many quality and regulatory efforts can pose a great challenge. The overlap of effort between compliance to various standards is common practice in industry. 

The MedTech Intelligence ISO 13485:2016 conference will establish the procedures that allow industry to comply with all relevant requirements while expending minimal effort. During this conference experts will provide the puzzle pieces necessary to see the full picture and put the puzzle together. 

Risk: One of the Emphases of ISO 13495:2016


In addition to the topics already mentioned, risk will be highly emphasized, not only in ISO 13485: 2016 but also in the new ISO 9001:2015. MasterControl’s Walt Murray will speak to the following nuances of healthy and robust risk management processes and to the following points:

  • Consideration of risk permeates the 13485 revision
  • 13485, 9001, 14971 and 31000
  • Management and operational consideration of risk
  • Risk-based approach to planning and product development
  • Requirement for remediation of risk files on legacy products
  • CEU Information

For those seeking CEUs, attendees of this conference can earn .1 CEU for each hour of the conference attended. Three weeks after the completion of the conference, MedTech Intelligence will provide attendees with a certificate of attendance displaying the number of CEUs earned. To view the full agenda: http://www.cvent.com/events/the-medtech-intelligence-13485-2016-conference/agenda-f911fff509464f69af7726fba709a738.aspx

Additional Details


Planner: Karen Devlin (Contact Karen: http://www.cvent.com/events/the-medtech-intelligence-13485-2016-conference/contactus-f911fff509464f69af7726fba709a738.aspx)



Marci Crane is MasterControl’s localization manager and a marketing communications specialist. 











Watch Related Videos:

BioMimetic Therapeutics
How MasterControl Makes Your Job Easier

Download Free Resources
White Paper: Engineering and Quality Teams in Medical Device Firms: Can We All Get Along?
Q&A: FDA Medical Device Investigator Offers Insights on Inspection
Q&A: Guidelines For The European Medical Device Vigilance System
Analyst Report: Risk Management: Best Practices for Medical Device Profitability
White Paper: Software Trends in the Medical Device Industry