Predictable Healthcare Product Approvals for Accelerated Global Market Access

Major advances in medical technologies over the last few decades have contributed to early diagnosis of diseases, more efficient delivery of treatment, and longer healthier lives. From switches to swipes, from hardware to apps or from the hospital to the home environment, healthcare devices continue to undergo a paradigm shift. To keep up with these advances, and to compete in a highly competitive and complex market, healthcare systems and medical devices must evolve to support and reflect this rapid pace of innovation. Ensuring that these systems and devices are safe for usage by both trained medical professionals as well as inexperienced home users is critical to business success and public safety. As a result, manufacturers find themselves in a constantly changing environment of safety, conformity and market access requirements – an environment in which they cannot afford to fall behind. To help our clients get their products to patients and healthcare professionals all over the world as safe and swiftly as possible, CSA Group responds to more than just the needs of today – we anticipate those of tomorrow. That is why we continuously advance our technical expertise in new and emerging technologies, constantly invest in developing knowledgeable staff to reliably serve our customers, and pay close attention to key international markets.

Seamless Service at Both Regional and Global Levels

As a global leader in healthcare systems conformity assessment services and unparalleled technical competence, CSA Group can help manufacturers get their products into markets around the world. We test and certify critical medical products, such as electro-medical devices and test & measurement equipment for labs, to required standards – including IEC 60601, IEC 61010 and IEC 62366. From cardiac defibrillators to CT scanning equipment, x-ray generators to operating tables, and microscopes to risk management process assessment and custom training on medical device standards, we focus on your needs, with experienced staff who are committed to working within your deadlines to deliver predictable and reliable service.

  • Competent Staff – We provide clients with access to experienced, highly knowledgeable and committed staff at all stages of product development. With expertise in offices across the globe, our staff can provide you with exceptional service at the local level.
  • Consistent and Cost Effective – We focus on helping minimize your time to market and overall costs of conformity assessment, leveraging our history and experience in the healthcare sector. We focus on delivering consistent and reliable services through high level of integration with your processes.
  • Coming Together for Customer Needs – We understand that speed and certainty about project deadlines are paramount when accessing global markets, and often this means working with relevant stakeholders who can help make this happen. We help in identifying and solidifying global strategic alliances where necessary with the goal of helping our customers bring their products to markets all over the world. This is one way we can offer a seamless “one-stop service” that best suits customer needs and goals.
We partner with you to certify, test, and audit quality and safety – across industries and around the world.
White Paper

Getting Electromedical Devices To North America

Navigating For Faster Market Access
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White Paper

Testing & Standards For An Evolving Medical Device Landscape

An Overview Of The 4th Edition Of IEC 60601-1-2 Medical Device EMC Standard
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Protecting Connected Devices Against Cyber Attack

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Your Testing & Certification Provider is Your Choice

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Transporting Your Lithium-ion Cells, Battery and Battery Assembly Products

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Event

Medica 2017

Location: Germany
November 13 - November 16, 2017
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Event

MedConf 2017

Location: Germany
October 16 - October 20, 2017
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Event

Medical Device Meetings 2018

Location: Germany
March 7 - March 8, 2018
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Webinar

Webinar: Medical Device Market Access FAQ

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Webinar

Webinar: Bringing Electro-Medical Products to North American and Global Markets

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Webinar

Webinar: Implications of the New MDR from a Product Testing and Certification Perspective

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Webinar

Webinar: The 4th Edition of the 60601-1-2 Medical Device EMC Standard

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