May 18, 2021 Ezra Kelderman

EU Medical Device Training: 4 Amazing Programs

Today’s most successful organizations commit to continuous learning. It’s what separates industry-leading medical device and pharmaceutical startups from the rest of the pack.

This mindset allows startup founders and other stakeholders to leverage new and emerging insights to craft high-value products and services.

However, in recent months, the European Union’s Medical Device Regulations (EU MDR) have required startup founders to shift their focus from manufacturing to compliance.

What is EU MDR?

EU MDR replaces EU MDD 993/42/EEC and 90/385/EEC. It outlines all of the procedural requirements that manufacturers must follow to build and distribute medical-related products. Failure to comply with these new standards and regulations prevents medical device manufacturers from importing, exporting, or selling products within the EU.

When you consider the complexity involved in ensuring that this transition runs smoothly, preparation is key. Fortunately, there are plenty of EU medical device training opportunities purpose-built to help manufacturers achieve rapid EU MDR compliance.

If you’re a startup founder that doesn’t shy away from continuous learning and improvement, we’ve devised a list of the industry’s top EU medical device training programs that are absolutely worth investing in.

EU Medical Device Training: Top 4 Programs

What exactly should you look for in an EU medical device training program? 

Prioritize programs created by industry-leading and reputable organizations, associations, and institutes. The right program will come backed with plenty of support and positive reviews. Ideally, the program should be issued by a known and trusted compliance expert with plenty of experience in medical device manufacturing in the EU.

With this in mind, here is a list of the top four medical device training programs that your startup or scale-up should consider investing in this year. 

1. The Association for the Advancement of Medical Instrumentation

In 1965, Robert D. Hall Jr. and Robert J. Allen founded The Association for the Advancement of Medical Instrumentation (AAMI). Today, AAMI serves as the leading organization for the development and enhancement of medical devices and other health-related products, services, and technologies.

AAMI committees outline the practices, procedures, and standards required to facilitate advanced safety and security of the world’s foremost medical devices. AAMI Standards Program Policies and Procedures document the processes AAMI committees follow to activate and manage various standards across the life sciences ecosystem.

In addition to these standards, AAMI offers a diverse curriculum of training and certification programs. Recently, AAMI hosted a program titled: Lead Auditor for Management Systems and Processes - Principles & Practices. During this event, auditors had the opportunity to learn more about EU MDR requirements and guidelines for conducting effective audits.

For a full list of programs, check this out.

2. Udemy

Udemy was founded in 2010 by Eren Bali, Gaga Biyani, and Oktay Caglar. It is one of the world’s largest and most successful online course providers. More than a million users routinely take on-demand courses on the platform.

With Udemy, you can choose from more than 130,000 online courses that cover a broad range of topics—including web development, data science drawing, marketing, photography, music, and more.

Use the search bar to conduct a search of courses related to EU MDR. The highest-rated EU MDR course is this: Medical Device Regulation 2017/745 EU Regulatory Affairs

In it, participants can access the most basic and pertinent EU MDR information, including an overview of Unique Device Identification (UDI), classification of medical devices, and post-market surveillance requirements.

For a full list of programs, check this out.

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3. British Standards Institute

The British Standards Institute (BSI) drives business improvement through the provision of certifications, programs, and standards across an array of industries and sectors. 

BSI is currently accredited by more than 20 governing bodies, including the American National Standards Institute and the United Kingdom Accreditation Service (UKAS).

What’s more, British Standards Institute offers a comprehensive list of training programs and courses, as well as a variety of EU MDR Transition Resources designed to help manufacturers achieve EU MDR compliance quickly and efficiently.

For a full list of programs, go here.

4. Regulatory Affairs Professionals Society

The Regulatory Affairs Professionals Society (RAPS) serves healthcare professionals, including those involved in medical device and pharmaceutical manufacturing. 

Today, RAPS supports more than 20,000 members worldwide by providing access to education, training, networking, and career development opportunities.

RAPS hosts digital events daily, ranging in topics such as CMC - An Integral Component of Cell and Gene Therapy Development and Clinical Evaluations for Unique Product Types under the EU MDR

For a full list of programs, go to their website.

Find an EU MDR Software Partner in Qualio

If you’re overwhelmed with the thought of achieving EU MDR compliance, you’re not alone. To create a smooth and seamless transition, we recommend partnering with one of the EU medical device training providers on our list.

Additionally, many of the world’s top medical device manufacturers have found a solid EU MDR software partner in Qualio. 

As an industry-leading electronic quality management system (eQMS) provider, we’ve helped the world’s brightest startups and scale-ups achieve rapid EU MDR compliance through the provision of a modern and flexible software solution.

 

Qualio is the first web-based eQMS purpose-built for medical device, pharmaceutical, and biotech companies. With Qualio, you can automate critical quality control processes and easily catalog and review new and evolving EU MDR requirements.

Is your current QMS checking all the boxes when it comes to EU MDR? 

To find out, we recommend downloading our free guide: 12 Questions to Ask Before You Buy an eQMS. Check it out, and you’ll have all the resources and insider intelligence needed to find an eQMS designed with your unique requirements in mind.

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Published by Ezra Kelderman May 18, 2021