ISO 13485:2016 Requirements for Quality Management Systems

Learn about the latest Quality Management System requirements for medical devices, known as ISO 13485:2016.  The requirements apply to organizations regardless of their size and regardless of their type except where specifically stated.

The discussion will include:

  • ISO 13485 Overview
  • Review Major ISO 13485:2016 Changes
  • FDA Case for Quality Initiative
  • eQMS and Design Control Harmonization
  • Medical Device Audit Readiness Plan
  • Live Q & A session


About the Presenters:

Rob LesnefskyRobert (Bob) Lesnefsky is the Global Vice President of Quality Assurance, Regulatory Compliance and Auditing at USDM Life Sciences. He is a seasoned quality assurance and regulatory compliance professional with 30+ years of experience in quality assurance and regulatory compliance in the pharmaceutical, biotechnology, medical device, nuclear and petrochemical industries. As a GMP/DEA compliance expert, he provides compliance auditing, consultations, interpretations and remediations of cGMP for Manufacturing, Operations, Quality and Client Services to ensure the compliance of drug production and medical device manufacturing. 


Amir Pirastehfar 85x105 rightAmir Pirastehfar is the Director of Product Lifecycle Management (PLM) Services and Solutions at USDM Life Sciences. He focuses on support and growth of PLM services. Amir has 20 years of technology, systems analysis, project management and product management experience.For part of his career, Amir owned the global Laboratory Information Management System (LIMS) at one of the largest biotech companies in the world. He also led all IS activities for implementation and enhancements of their CRM System.


David Wolf 3David Wolf is a Certified Quality Engineer & Biomedical Auditor at PTC. Prior to joining PTC, David worked for medical device manufacturing companies in a variety of roles. He has designed, patented and released several product lines for worldwide distribution. David has hands on expertise in product development, manufacturing, supply chain, regulatory and quality management.  He was a catalyst that drove and managed the PTC Medical Device Value Ready Deployment (VRD), which significantly reduces the implementation time and cost for mid-market companies.  He’s been working with top tier medical device manufacturers while here at PTC and holds several medical device patents.

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  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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