The Medical Device Regulations, Guidelines and ISO Standards

Description
Regulatory

Today we are at the eve of the biggest change in the Medical Device Legislation in the last 20 years.

Significant technological and scientific progress in the Medical Device field and the need to ensure a consistent high level of patient safety were the most important triggers for the creation of the new EU Medical Device Regulation (MDR) and the updates to the MEDDEV guidelines and the ISO14155 Standard. The EU MDR will effectively replace the Medical Device Directive (93/42/EEC) and Active Implantable Medical Device Directive (90/385/EEC).

Next to a brief overview of the present state of the industry, this TRIUM Session will mainly focus on what to expect for the future with regards to these changes in the legislation, like the product scope expansions, the more stringent clinical evidence and the more rigorous post-market oversight requirements amongst others.

At the end, you will receive a certificate and handy hand-outs for later use.

Learning objectives

By the end of this TRIUM Training you should be able to:

  • Describe the history of device standards, directives and guidelines to date
  • Explain the current and/or expected changes in the relevant EU Medical Device Regulation, MEDDEV guidelines and ISO14155 standards
Intended audience

Fundamental Level
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.

Trainer
Esther Daemen
Esther Daemen is currently ‘Quality &Training Director – Data Protection manager’ at TRIUM Clinical Consulting and has over 27 years of working experience in the healthcare/pharma & device field. She served many organizations in different research roles and as professional development director at ACRP global. She gained a bachelor’s in nursing and earned project management, training and DPO certificates as well as and a master´s degree in Business. Esther is also a highly sought-after presenter at professional conferences/universities and a writer of peer-reviewed articles for professional magazines like ‘The Clinical Researcher’. Her work was rewarded by the KP Morgan 'OECT Summit 10Years Speaker Achievement Award' in 2020, the ‘Best trainer to watch’ 2010 Training Magazine award and by having her organization ‘Kendle’ being listed as one of the top 125 training providers in the world in 2008. "TRIUM is an expert Contract Research Organization that offers a unique combination of global CRO services, staffing solutions, quality services, GDPR consultancy and risk-based approaches as well as training services. It’s our mission to be a passionate, dedicated business partner with a focus on excellence to provide start‐to‐finish clinical trial activities tailored to the timing, budget and specific needs of the Sponsor.”