{"id":7913,"date":"2026-07-03T13:56:21","date_gmt":"2026-07-03T11:56:21","guid":{"rendered":"https://briskr.nl/nl/?post_type=jku-events&p=7913"},"modified":"2026-09-10T19:59:37","modified_gmt":"2026-09-10T17:59:37","slug":"https-briskr-nl-events-us-or-europe-first-choosing-your-regulatory-clinical-path","status":"publish","type":"jku-events","link":"https://briskr.nl/nl/events/https-briskr-nl-events-us-or-europe-first-choosing-your-regulatory-clinical-path/","title":{"rendered":"US or Europe First? Choosing Your Regulatory & Clinical Path"},"content":{"rendered":"\n

Bringing an innovative medical device to market is about much more than developing great technology. Understanding the regulatory landscape early on can save valuable time, reduce risks and help you make better strategic decisions throughout your product development journey.

\n\n\n\n

In this practical workshop, regulatory experts from Qserve will guide you through the key differences and similarities between the European and US regulatory pathways for medical devices. Through practical examples, you’ll gain insight into how your product is classified, what evidence is required and how to plan your route to market.

\n\n\n\n

The second part of the workshop allows for more in-depth discussions tailored to software and AI-based medical devices.

\n\n\n\n

Whether you are still validating your idea or preparing for market entry, this workshop will help you better understand the regulatory and clinical considerations that can influence your development strategy.

\n\n\n\n

What will you learn?

\n\n\n\n\n\n\n\n

Speakers

\n\n\n\n
Robert Paassen, Team Manager Regulatory Medical Devices & Senior Consultant | Qserve
\n\n\n\n

Robert has extensive experience in regulatory affairs for medical devices and supports innovative companies in developing efficient regulatory strategies for both European and international markets. During this workshop, he will explain the regulatory fundamentals and help startups understand the key decisions they need to make early in product development.

\n\n\n\n

Coenraad Davidsdochter, Team Manager Regulatory Medical Devices & Senior Consultant | Qserve

\n\n\n\n

Coenraad specializes in software, AI-based and active medical devices and supports companies in navigating the regulatory requirements for these rapidly evolving technologies.

\n\n\n\n
\n
\n
\n
\n
\n
\n Register here\n
\n
\n
\n
\n

Choose your point of entry wisely!

\n
\n
\n
\n
\n

Error: Contact form not found.

\n
\n
\n
\n\n\n\n

Location
Meet&Greet, Noviotech Campus Nijmegen.

\n\n\n\n

Good to know
The workshop is facilitated in English and is free of charge.

\n\n\n\n

Participation in the workshop is free for everyone, including drinks and bites. However, for noshow and cancellations within 24 hours prior to the event, we will charge a fee of 15 euros (excluding VAT) to cover incurred expenses. By signing up, you agree to this term.

\n\n\n\n
\"\"
\n","protected":false},"excerpt":{"rendered":"

Bringing an innovative medical device to market is about much more than developing great technology. Understanding the regulatory landscape early on can save valuable time,...

\n","protected":false},"featured_media":7915,"template":"","categories":[2],"tags":[8],"jku-businessfase":[11,10],"class_list":["post-7913","jku-events","type-jku-events","status-publish","has-post-thumbnail","hentry","category-regulations","tag-health","jku-businessfase-start-up","jku-businessfase-scale-up"],"acf":[],"yoast_head":"\nUS or Europe First? Choosing Your Regulatory & Clinical Path - Briskr\n\n\n\n\n\n\n\n\n\n\n\t\n\t\n\t\n\n\n\t\n\n","yoast_head_json":{"title":"Eerst de VS of Europa? De keuze van uw regelgevings- en klinische traject - Briskr","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https://briskr.nl/nl/events/https-briskr-nl-events-us-or-europe-first-choosing-your-regulatory-clinical-path/","og_locale":"nl_NL","og_type":"article","og_title":"US or Europe First? Choosing Your Regulatory & Clinical Path - Briskr","og_description":"Bringing an innovative medical device to market is about much more than developing great technology. Understanding the regulatory landscape early on can save valuable time,...","og_url":"https://briskr.nl/nl/events/https-briskr-nl-events-us-or-europe-first-choosing-your-regulatory-clinical-path/","og_site_name":"Briskr","article_modified_time":"2026-09-10T17:59:37+00:00","og_image":[{"width":2400,"height":1600,"url":"https://briskr.nl/wp-content/uploads/2026/07/Workshop-22-sept-MDR-icoontjes.jpg","type":"image/jpeg"}],"twitter_card":"summary_large_image","twitter_misc":{"Est. reading time":"2 minutes"},"schema":{"@context":"https://schema.org","@graph":[{"@type":"WebPage","@id":"https://briskr.nl/nl/events/https-briskr-nl-events-us-or-europe-first-choosing-your-regulatory-clinical-path/","url":"https://briskr.nl/nl/events/https-briskr-nl-events-us-or-europe-first-choosing-your-regulatory-clinical-path/","name":"US or Europe First? Choosing Your Regulatory & Clinical Path - Briskr","isPartOf":{"@id":"https://briskr.nl/nl/#website"},"primaryImageOfPage":{"@id":"https://briskr.nl/nl/events/https-briskr-nl-events-us-or-europe-first-choosing-your-regulatory-clinical-path/#primaryimage"},"image":{"@id":"https://briskr.nl/nl/events/https-briskr-nl-events-us-or-europe-first-choosing-your-regulatory-clinical-path/#primaryimage"},"thumbnailUrl":"https://briskr.nl/wp-content/uploads/2026/07/Workshop-22-sept-MDR-icoontjes.jpg","datePublished":"2026-07-03T11:56:21+00:00","dateModified":"2026-09-10T17:59:37+00:00","breadcrumb":{"@id":"https://briskr.nl/nl/events/https-briskr-nl-events-us-or-europe-first-choosing-your-regulatory-clinical-path/#breadcrumb"},"inLanguage":"nl-NL","potentialAction":[{"@type":"ReadAction","target":["https://briskr.nl/nl/events/https-briskr-nl-events-us-or-europe-first-choosing-your-regulatory-clinical-path/"]}]},{"@type":"ImageObject","inLanguage":"nl-NL","@id":"https://briskr.nl/nl/events/https-briskr-nl-events-us-or-europe-first-choosing-your-regulatory-clinical-path/#primaryimage","url":"https://briskr.nl/wp-content/uploads/2026/07/Workshop-22-sept-MDR-icoontjes.jpg","contentUrl":"https://briskr.nl/wp-content/uploads/2026/07/Workshop-22-sept-MDR-icoontjes.jpg","width":2400,"height":1600},{"@type":"BreadcrumbList","@id":"https://briskr.nl/nl/events/https-briskr-nl-events-us-or-europe-first-choosing-your-regulatory-clinical-path/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https://briskr.nl/nl/"},{"@type":"ListItem","position":2,"name":"Events","item":"https://briskr.nl/nl/events/"},{"@type":"ListItem","position":3,"name":"US or Europe First? Choosing Your Regulatory & Clinical Path"}]},{"@type":"WebSite","@id":"https://briskr.nl/nl/#website","url":"https://briskr.nl/nl/","name":"Briskr","description":"","publisher":{"@id":"https://briskr.nl/nl/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https://briskr.nl/nl/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"nl-NL"},{"@type":"Organization","@id":"https://briskr.nl/nl/#organization","name":"Briskr","url":"https://briskr.nl/nl/","logo":{"@type":"ImageObject","inLanguage":"nl-NL","@id":"https://briskr.nl/nl/#/schema/logo/image/","url":"https://briskr.nl/wp-content/uploads/2022/02/Briskr-favicon.png","contentUrl":"https://briskr.nl/wp-content/uploads/2022/02/Briskr-favicon.png","width":512,"height":512,"caption":"Briskr"},"image":{"@id":"https://briskr.nl/nl/#/schema/logo/image/"}}]}},"_links":{"self":[{"href":"https://briskr.nl/nl/wp-json/wp/v2/jku-events/7913","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https://briskr.nl/nl/wp-json/wp/v2/jku-events"}],"about":[{"href":"https://briskr.nl/nl/wp-json/wp/v2/types/jku-events"}],"wp:featuredmedia":[{"embeddable":true,"href":"https://briskr.nl/nl/wp-json/wp/v2/media/7915"}],"wp:attachment":[{"href":"https://briskr.nl/nl/wp-json/wp/v2/media?parent=7913"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https://briskr.nl/nl/wp-json/wp/v2/categories?post=7913"},{"taxonomy":"post_tag","embeddable":true,"href":"https://briskr.nl/nl/wp-json/wp/v2/tags?post=7913"},{"taxonomy":"jku-businessfase","embeddable":true,"href":"https://briskr.nl/nl/wp-json/wp/v2/jku-businessfase?post=7913"}],"curies":[{"name":"wp","href":"https://api.w.org/{rel}","templated":true}]}}