Navigate regulations
and bring your devices safely to maket.

Pragmatic support to register your medical devices and comply with regulations.

We’ve invested in developing effective and proven processes to prepare regulatory submissions which can be tailored to your needs.

Whether its FDA, European, UK or Brazilian market access you’re after, we can help you prepare, curate and achieve regulatory clearance for your devices.

If you need some additional resource or a trusted partner to oversee your regulatory activity, we’re here to help.

If you're entering the medical devices market for the first time or an established enterprise expanding your product range, we're here to help you make sense of regulatory frameworks and get your products registered.

Regulatory Services

We’ll help you avoid regulatory pitfalls and develop devices in a traceable and defensible way.

Engage with us early and we can map out a regulatory strategy, good practice ways of working and evidence requirements. You’ll avoid building up regulatory debt you”ll have to address before you get market access.

If you’re looking for a partner to prepare your regulatory evidence and navigate your regulatory pathway, we’d be happy to have a chat.

And if you’re further down the tracks we can provide an independent view of your draft regulatory submissions or help manage communications with regulatory authorities. Our expertise includes:

Regulatory Strategy: making sure you have a credible, sequenced path to achieve your regulatory goals for different market requirements.

Readiness: highlighting any potential deficiencies in your regulatory submissions with a gap analysis or completeness review before you submit to the regulator, protecting your regulatory timeline and avoidiing hard to fix issues.

Preparation: helping you curate your supporting evidence, drafting and presenting your regulatory submission effectively.

Submission: managing pre-submission and submission processes, selecting notified bodies, communicating with regulators and resolving observations and issues during the external review.

US: FDA exemption discretion, 513g, 510k regulatory approvals.

CE: class 1 & 2a/2b software as a medical device

UK: class 1 & 2a/2b software as a medical device

Brazil: Anvisa registration

.. but if we don’t have the expertise you need, we probably know someone who does.