SaMD and AI medical device regulatory compliance
SaMD and AI medical device regulatory compliance
We review medical AI and other devices to ensure conformity with relevant regulations, offering a range of product review services to help bring your device to market.
Our regulatory compliance team works alongside yours to plan the right route under EU MDR and FDA regulations, covering IEC 62304, cybersecurity for connected medical devices, and EU AI Act readiness. We then prepare your CE marking technical documentation or FDA 510(k) submission and stay with you as your point of contact until approval.
Our SaMD and AI medical device regulatory compliance experts consider information about your medical device including
Intended purpose and classification
What your software does, who uses it and in which clinical setting. This determines whether it qualifies as a medical device and its risk class under MDR Rule 11 and FDA classification.
Labelling and claims
Every claim you make must be supported by evidence that a Notified Body or the FDA will accept. We align your claims with your evidence before submission, not after.
Available preclinical and clinical information
We assess your existing clinical data, literature and performance studies and identify gaps early, so they do not turn into reviewer questions later.
Software and cybersecurity documentation
We review your IEC 62304 lifecycle documentation, risk management and cybersecurity controls against current EU and FDA expectations.
Intended purpose and classification
What your software does, who uses it and in which clinical setting. This determines whether it qualifies as a medical device and its risk class under MDR Rule 11 and FDA classification.
Labelling and claims
Every claim you make must be supported by evidence that a Notified Body or the FDA will accept. We align your claims with your evidence before submission, not after.
Available preclinical and clinical information
We assess your existing clinical data, literature and performance studies and identify gaps early, so they do not turn into reviewer questions later.
Software and cybersecurity documentation
We review your IEC 62304 lifecycle documentation, risk management and cybersecurity controls against current EU and FDA expectations.
Based on this information, our team of medical device regulatory compliance experts will recommend the market entry strategy for your target markets and outline the required technical, preclinical, and clinical information. The easiest way to start is to book a 30 minute call with one of our specialists.
Regulatory pathways and submissions
Regulatory pathways and submissions
EU MDR Technical Documentation and CE marking
For most SaMD, AI and connected medical devices, a Notified Body must review your technical documentation before CE marking. We prepare it according to MDR Annex II and III, guide you through the Notified Body review and register your device in EUDAMED once it is certified.
FDA 510(k) Premarket Notification
If a legally marketed device with the same intended use already exists, a 510(k) is usually the fastest route to the US market. We identify the right predicate, build your substantial equivalence argument and manage FDA questions through to clearance.
De Novo Classification Requests
When your device is new and no suitable predicate exists, De Novo creates a new classification for low to moderate risk devices. We prepare the request and the evidence behind it, and your device can then serve as a predicate for future products.
Premarket Approval Applications (PMAs)
Class III devices, including some high risk diagnostic software, require Premarket Approval. We support your PMA together with the clinical evidence it depends on.
513(g) Requests for Classification
Not sure how the FDA will classify your device? A 513(g) request gives you the FDA’s formal view on classification and the applicable pathway before you invest in a full submission.
FDA Pre-Submission (Q-Sub)
A Pre-Submission lets you agree on your testing, clinical, and submission strategy with the FDA before you commit to it. We prepare the request and support you in the meeting. In the EU, we coordinate structured dialogue with your Notified Body.
Clinical Investigation Applications
When existing clinical data is not enough to support your claims, a clinical investigation is needed. We prepare IDE applications for the FDA and clinical investigation applications under the EU MDR, so your study can start on time.
EU MDR Technical Documentation and CE marking
For most SaMD, AI and connected medical devices, a Notified Body must review your technical documentation before CE marking. We prepare it according to MDR Annex II and III, guide you through the Notified Body review and register your device in EUDAMED once it is certified.
FDA 510(k) Premarket Notification
If a legally marketed device with the same intended use already exists, a 510(k) is usually the fastest route to the US market. We identify the right predicate, build your substantial equivalence argument and manage FDA questions through to clearance.
De Novo Classification Requests
When your device is new and no suitable predicate exists, De Novo creates a new classification for low to moderate risk devices. We prepare the request and the evidence behind it, and your device can then serve as a predicate for future products.
Premarket Approval Applications (PMAs)
Class III devices, including some high risk diagnostic software, require Premarket Approval. We support your PMA together with the clinical evidence it depends on.
513(g) Requests for Classification
Not sure how the FDA will classify your device? A 513(g) request gives you the FDA’s formal view on classification and the applicable pathway before you invest in a full submission.
FDA Pre-Submission (Q-Sub)
A Pre-Submission lets you agree on your testing, clinical, and submission strategy with the FDA before you commit to it. We prepare the request and support you in the meeting. In the EU, we coordinate structured dialogue with your Notified Body.
Clinical Investigation Applications
When existing clinical data is not enough to support your claims, a clinical investigation is needed. We prepare IDE applications for the FDA and clinical investigation applications under the EU MDR, so your study can start on time.
Authorized representative
Authorized representative
EU Authorised Representative
Manufacturers outside the EU must appoint an Authorised Representative under MDR Article 11. We take on this role, keep your technical documentation and declaration of conformity available to authorities, register your device in EUDAMED and act as your contact point with EU competent authorities.
EU Representative for Clinical Investigations
Sponsors outside the EU need a legal representative to run a clinical investigation in Europe under MDR Article 62. We act in this role and handle communication with authorities and ethics committees throughout your study.
FDA Establishment Registration/ Device Listing
Every establishment involved in producing devices for the US market must register with the FDA and list its devices each year. We manage the registration and annual updates, so your device stays legally on the market.
FDA US Agent for Foreign Establishments
Foreign establishments must name a US Agent based in the United States. Through our US partner, we act as your US Agent and handle routine FDA communication on your behalf.
EU Authorised Representative
Manufacturers outside the EU must appoint an Authorised Representative under MDR Article 11. We take on this role, keep your technical documentation and declaration of conformity available to authorities, register your device in EUDAMED and act as your contact point with EU competent authorities.
EU Representative for Clinical Investigations
Sponsors outside the EU need a legal representative to run a clinical investigation in Europe under MDR Article 62. We act in this role and handle communication with authorities and ethics committees throughout your study.
FDA Establishment Registration/ Device Listing
Every establishment involved in producing devices for the US market must register with the FDA and list its devices each year. We manage the registration and annual updates, so your device stays legally on the market.
FDA US Agent for Foreign Establishments
Foreign establishments must name a US Agent based in the United States. Through our US partner, we act as your US Agent and handle routine FDA communication on your behalf.