Innovenn
  • Company
    • About Innovenn
    • Our Team
    • Partnerships and Affiliations
    • Culture
    • Careers
  • Consulting Services
    • Software as a Medical Device (SaMD) Development
      • Clinical Decision Support Software (CDSS)
      • Digital Therapeutics (DTx)
      • Validation of DHTs (Digital Health Technologies) for use in Clinical Investigations
      • Clinical Evaluation for SaMD
      • Data Governance for SaMD
      • Regulatory Services for SaMD Products
      • Medical Device Cybersecurity
    • Medical Device Development Consulting
      • The Process of Medical Device Concept Development and Feasibility
      • Design Control Management
      • Clinical Evaluation
      • Clinical Investigation
      • Risk Management
      • Bluetooth Validation
    • Human Factors and Usability Engineering
    • Regulatory Planning and Submissions Consulting
      • Medical & Regulatory Writing
      • 510(k) & FDA Guidance
      • The LDT (Laboratory Developed Test) Regulatory Landscape
      • Premarket Approval (PMA)
      • De Novo
      • Importance of Clinical Data in Premarket Approval
      • FDA Label Regulations
      • EU MDR
      • UK MDR
    • Drug Development Consulting
      • Prescription to Over-the-Counter Switch
    • Program and Technical Project Management
      • Patient-Centered Design and Approach to Product Development
    • Quality Management Systems (QMS) Consulting
      • QMS Audit Services: Preparation, Response and Corrective Action Support
    • Specialized Life Sciences Consulting
  • Who We Work With
    • Software as a Medical Device (SaMD) and Digital Therapeutics
    • Medical Device
    • Pharmaceutical
    • Biotechnology
    • Venture-backed Startups
  • Products Portfolio
    • Software as a Medical Device (SaMD) and Digital Therapeutics
    • Machine Learning and Artificial Intelligence
    • Medical Devices
    • Combination Products
    • Wearable Medical Devices
  • Resources
    • Testimonials
    • News
    • Case Studies
    • Videos
    • Blogs
    • Events
  • Contact
  • Linkedin
  • Menu Menu
  • Company
    • About Innovenn
    • Our Team
    • Partnerships and Affiliations
    • Culture
    • Careers
  • Consulting Services
    • Software as a Medical Device (SaMD) Development
      • Clinical Decision Support Software (CDSS)
      • Digital Therapeutics (DTx)
      • Validation of DHTs (Digital Health Technologies) for use in Clinical Investigations
      • Clinical Evaluation for SaMD
      • Data Governance for SaMD
      • Regulatory Services for SaMD Products
      • Medical Device Cybersecurity
    • Medical Device Development Consulting
      • The Process of Medical Device Concept Development and Feasibility
      • Design Control Management
      • Clinical Evaluation
      • Clinical Investigation
      • Risk Management
      • Bluetooth Validation
    • Human Factors and Usability Engineering
    • Regulatory Planning and Submissions Consulting
      • Medical & Regulatory Writing
      • 510(k) & FDA Guidance
      • The LDT (Laboratory Developed Test) Regulatory Landscape
      • Premarket Approval (PMA)
      • De Novo
      • Importance of Clinical Data in Premarket Approval
      • FDA Label Regulations
      • EU MDR
      • UK MDR
    • Drug Development Consulting
      • Prescription to Over-the-Counter Switch
    • Program and Technical Project Management
      • Patient-Centered Design and Approach to Product Development
    • Quality Management Systems (QMS) Consulting
      • QMS Audit Services: Preparation, Response and Corrective Action Support
    • Specialized Life Sciences Consulting
  • Who We Work With
    • Software as a Medical Device (SaMD) and Digital Therapeutics
    • Medical Device
    • Pharmaceutical
    • Biotechnology
    • Venture-backed Startups
  • Products Portfolio
    • Software as a Medical Device (SaMD) and Digital Therapeutics
    • Machine Learning and Artificial Intelligence
    • Medical Devices
    • Combination Products
    • Wearable Medical Devices
  • Resources
    • Testimonials
    • News
    • Case Studies
    • Videos
    • Blogs
    • Events
  • Contact
  • LinkedIn
Blog - Latest News
News

Innovenn and Ateleris GmbH Announce Strategic Collaboration

MADISON, Wisc. — Innovenn, a premier boutique consultancy specializing in strategic regulatory affairs, product development, and human factors engineering for complex health technologies, today announced a strategic partnership with Ateleris GmbH, a Swiss-based leader in software engineering and applied R&D. Together, the firms will deliver advanced, data-driven, and AI-enabled solutions to accelerate safe, effective, and globally compliant innovations across pharmaceutical, medical device, and digital health markets.

This collaboration brings together Innovenn’s deep regulatory, clinical, and market access expertise with Ateleris’ capabilities in algorithm design, machine learning, optimization, and embedded software. Together, the firms will co-create novel tools and insights to support the development, launch, and oversight of regulated products—particularly in the fast-growing areas of Software as a Medical Device (SaMD), digital diagnostics, digital therapeutics, and connected health technologies.

We are excited to join forces with Ateleris to push the boundaries of what’s possible in regulated health innovation,” said Mary E. Dixon, CEO of Innovenn, Inc. “This partnership combines our deep regulatory, product development and human factors expertise with Ateleris’ advanced engineering and AI capabilities, empowering clients to bring safer, smarter, and more patient-centered solutions to market faster. Together, we are shaping a new era of transformative healthcare technologies.”

Ateleris, based in Brugg AG, Switzerland, brings a strong track record of success in applying artificial intelligence and software engineering across sectors including space, energy, and logistics. This partnership marks their first dedicated entry into the life sciences domain, supported by Innovenn’s expertise in FDA, EU, and global regulatory environments.

“Working with Innovenn allows us to bring our engineering expertise to high-impact healthcare applications,” said Laszlo Etesi, CEO and Co-Founder of Ateleris. “We look forward to applying technology where it matters by co-developing intelligent systems that improve decision-making, patient outcomes, and product development efficiency.”

The partnership will launch with pilot solutions that explore software and AI solutions for regulatory planning and submission, usability analytics, and intelligent risk mitigation for digital health products, SaMD, and other regulated health technology.

For more information, please visit our websites (www.innovenn.com and https://www.ateleris.ch/) or contact Katie Brunner at katieb@innovenn.com.

About Innovenn

Innovenn, a trusted boutique consultancy redefining how regulated health innovations reach patients, partners with global pharma, biotech, and medical device leaders to deliver breakthrough products with speed, rigor, and compassion. By integrating strategic regulatory guidance, human-centered design, and strategic evidence generation, Innovenn helps innovators turn transformative ideas into meaningful patient impact.

Founded in 2014, Innovenn, is a Madison-based consultancy specializing in regulatory strategy, product development, human factors engineering, and digital innovation for life sciences. The team has supported hundreds of projects spanning combination products, Software as a Medical Device (SaMD), and advanced therapeutics — helping clients achieve global approvals and market readiness faster. Innovenn stands apart as a preferred global partner for those seeking science-driven, patient-centered, and high-integrity product development support.

About Ateleris GmbH

Ateleris is a software engineering firm delivering IT consulting, IT project management, and software architecture and design through agile software development, algorithm engineering, and software service platform options. With a strong heritage in running applied research and development projects, along with roots in space research and a passion for technological innovation, Ateleris transforms complex data into actionable insight. They are headquartered in Brugg, Switzerland.

July 14, 2025/by Innovenn
/wp-content/uploads/2023/07/Innovenn-Primary-Logo-300x75.png 0 0 Innovenn /wp-content/uploads/2023/07/Innovenn-Primary-Logo-300x75.png Innovenn2025-07-14 11:00:252026-02-25 09:55:19Innovenn and Ateleris GmbH Announce Strategic Collaboration

Stay Informed

Join the 4000+ readers who stay informed with our monthly newsletter.

Sign Me Up

Search Search

Categories

  • Blog (4)
  • Get to Know Us (4)
  • News (2)
  • Press Release (1)
  • SaMD (1)
Innovenn logo
Where healthcare innovation intersects with improved patient outcomes
Contact Us
Contact Innovenn

Global reach from Wisconsin HQ. Serving clients in the US, EU, UK & Canada

6410  Enterprise Lane
Suite 230
Madison, WI 53719

608-203-9748

info@innovenn.com

Stay Informed

Sign up to get the latest industry news, insights and tips.

Sign Me Up
Search Search
© 2026 All rights reserved. | Privacy Policy | Terms of Use | WordPress Web Design by Bizzy Bizzy
Link to: Patient Centric Culture Link to: Patient Centric Culture Patient Centric CultureNurse holding hands with elderly patient
Scroll to top Scroll to top Scroll to top

This site uses cookies. By continuing to browse the site, you are agreeing to our use of cookies.

Accept settingsHide notification onlySettings

Cookie and Privacy Settings



How we use cookies

We may request cookies to be set on your device. We use cookies to let us know when you visit our websites, how you interact with us, to enrich your user experience, and to customize your relationship with our website.

Click on the different category headings to find out more. You can also change some of your preferences. Note that blocking some types of cookies may impact your experience on our websites and the services we are able to offer.

Essential Website Cookies

These cookies are strictly necessary to provide you with services available through our website and to use some of its features.

Because these cookies are strictly necessary to deliver the website, refusing them will have impact how our site functions. You always can block or delete cookies by changing your browser settings and force blocking all cookies on this website. But this will always prompt you to accept/refuse cookies when revisiting our site.

We fully respect if you want to refuse cookies but to avoid asking you again and again kindly allow us to store a cookie for that. You are free to opt out any time or opt in for other cookies to get a better experience. If you refuse cookies we will remove all set cookies in our domain.

We provide you with a list of stored cookies on your computer in our domain so you can check what we stored. Due to security reasons we are not able to show or modify cookies from other domains. You can check these in your browser security settings.

Google Analytics Cookies

These cookies collect information that is used either in aggregate form to help us understand how our website is being used or how effective our marketing campaigns are, or to help us customize our website and application for you in order to enhance your experience.

If you do not want that we track your visit to our site you can disable tracking in your browser here:

Other external services

We also use different external services like Google Webfonts, Google Maps, and external Video providers. Since these providers may collect personal data like your IP address we allow you to block them here. Please be aware that this might heavily reduce the functionality and appearance of our site. Changes will take effect once you reload the page.

Google Webfont Settings:

Google Map Settings:

Google reCaptcha Settings:

Vimeo and Youtube video embeds:

Other cookies

The following cookies are also needed - You can choose if you want to allow them:

Privacy Policy

You can read about our cookies and privacy settings in detail on our Privacy Policy Page.

Privacy Policy
Accept settingsHide notification only

Sign up to get the latest industry news, insights and tips.

Name(Required)