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Digital Health Products

De-risking your digital health technology development by applying optimal regulatory frameworks at an early stage​

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revolutionize healthcare digital health solutions

KEY FIGURES

100+

Innovative digital technologies assisted

30+

EU/US MD regulatory applications supported

20+

Health authority interactions

Proven Track Record with​ Disruptive Digital Technologies

  • Deep knowledge in complex regulatory frameworks ​
  • Proven experience in regulatory agency engagement​
  • Collaborating with regulatory bodies, associations, and expert groups leading the evolution of the digital health regulatory framework

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Comprehensive Expertise in Digital Health​​ Solutions Development, Validation, and Data Security​

  • Mobile medical applications​
  • AI/ML based devices (SaMD, DTx, CDS, CAD)​
  • Virtual reality/augmented reality, and robotic systems ​
  • Telemonitoring and telemedecine systems​
  • Wearable, connected devices ​

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Discover our insights on digital health products

Webinar

Sep 17 2020

How to create an aligned global co-development strategy for drug with device component combination products

Published on: Sept 17th, 2020   Drug delivery tech…

  • Medical device
Blog

Nov 10 2020

TOPRA/RAPS workshop on alignment of global combination products

  • Medical device
  • Combination Products
Blog

Mar 30 2019

Addressing the impact of the EU medical devices regulation on combination products

An inter-regulatory and stakeholder workshop on co…

  • Medical device
  • Regulatory strategy
All insights

FAQs

What are the key US/EU regulatory differences impacting the development of a software as a medical device (SaMD) product?

Both US and the EU follow a risk-based approach in terms of classification and therefore applicable requirements for devices. ​

 

Regulatory conformity is established against similar key recognized standards (i.e., IEC 62034). In the EU, CE marking is focused on safety and performance whereas FDA approvals primarily consider safety and effectiveness.

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What are the typical challenges for innovative, software-based devices to access the US market, taking the 510K route?

The most common challenge for innovative medical device software following the 510K route is making sure that you meet the definition of a 510K (i.e., the same intended use and the same fundamental technology as the predicate device). 

 

The whole basis of your 510K is to demonstrate through existing performance data or existing special controls that your device is just as safe and effective as the predicate device.

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Are there any medtech health innovation programs proposed by the authorities that can be utilized to facilitate market entry in the US and in Europe?

There are several different types of Q submissions that the FDA has put out in guidance. 

 

The most applicable is usually a pre-submission used to de-risk any future marketing application. In addition, you also have the Breakthrough Devices program. At an EU wide level, innovation programs are available based on national initiatives (i.e., the ANSM’s “Guichet Innovation” in France, and the Innovative Devices Access Pathway (IDAP) by the MHRA in the UK).

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Can SaMD validation data recognized by European regulators also be used to support a US submission?​

Differences between the EU and the US will usually be in terms of clinical practice and patient population. ​

 

In this case you will have to be able to demonstrate to the FDA that the data you already have would be applicable to the US (i.e., usability, clinical evidence). So, if any studies were conducted and focused on the EU population only, you have to be able to demonstrate how the differences in the US have been considered. In addition, the FDA is always looking at harmonization, especially with the recognition of standards. The standards databases are constantly being evaluated and updated as international standards are published.

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Related Glossary

SaMD / SiMD
IEC 62304
SOUP
Digital Therapeutics (DTx)
Pre-Submission Meeting
Breakthrough Device Designation

Questions? Get the answers from our expert team ​

No two product development paths are the same. Talk to our experts about your development challenges and we will provide you actionable recommendations.​

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Solutions you may be interested in

Early-Stage Clinical Development

Guiding your early-stage clinical development with precision and care. We ensure robust studies that build a solid foundation for your therapy’s future success, while seamlessly integrating market access, patient, and regulatory aspects.

Late-Stage Clinical Development

Begin with the end in mind to advance your innovative product development in Europe.

Regulatory Services

From strategy, implementation to maintenance, we offer a multi-disciplinary regulatory service to expedite your product development and to streamline regulatory process.

Patient Engagement

Including patient voices at all stages of your product’s life cycle is critical. Systematically-embedded patient perspectives help sponsors to develop a value proposition and a solution integrating real-life insights. Developing a strategic patient engagement plan will help clients de-risk clinical trials and optimize access to market.

Clinical Safety Management

A multi-disciplinary approach to identify, assess, and minimize risks. We help you ensure the safety of patients and establish the safety profile of the drug in a controlled setting, supporting its regulatory approval.