Regulatory Affairs

Regulatory, done right first time.

JReg are here to support and/or manage your global Regulatory Affairs projects, including strategic planning through to executional ‘hands-on’ regulatory and technical writing on both pre-market and post-market stages of all medical devices.

Our consultants have extensive experience in all areas of technical documentation preparation, writing and reviewing, as well as submissions with Notified and Approved Bodies.

Our experienced consultants provide assistance in achieving and maintaining CE mark certification, UKCA mark, FDA 510k clearances, PMA approvals and global registrations.

JReg place highly experienced consultants to deliver each of our projects. By providing the right level of experience to the right project, we deliver more efficiently and to a higher standard of quality and compliance.

Regulatory strategy

A well-defined regulatory strategy is crucial for any medical device or in vitro diagnostic manufacturer aiming to successfully navigate the complex global regulatory landscape.

A comprehensive regulatory strategy provided by JReg ensures that your product meets all relevant regulatory requirements for market entry, streamlines development, reduces time to market, and helps prevent costly delays. This initial strategic document will clearly classify your device and identify applicable regulatory requirements across target markets.

Where possible we will conduct a Regulatory Gap Assessment to benchmark current compliance status against market-specific requirements, identifying required documentation, clinical evidence, quality system adjustments, notified body expectations, and timelines.

Technical Documentation – compiling and submission

JReg provides the option to fully manage projects on behalf of clients, handling all aspects from regulatory strategy development through to implementation, ensuring seamless execution and compliance.

Alternatively, we offer tailored coaching and support services to empower a client’s internal team, providing the guidance and expertise needed for you to confidently complete the work independently.

This flexible approach allows JReg clients to choose the level of involvement that best fits your resources and business goals.

Get in Touch

Frequently Asked Questions

We support all classes of medical devices (Class I, IIa, IIb, III), including software as a medical device (SaMD), in vitro diagnostic (IVD) devices, combination products, and digital health technologies.

We assist with regulatory submissions globally, including the EU (CE Marking), UK (UKCA Mark), USA (FDA 510(k), De Novo, PMA), Canada, Australia, and other international markets.

Yes, we support the full lifecycle — from strategic regulatory planning and initial submissions to post-market surveillance, vigilance reporting, and documentation updates.

Absolutely. We specialise in compiling, reviewing, and maintaining technical documentation in line with MDR, IVDR, and other global requirements.

We provide mock audits, gap assessments, and audit readiness training. We also support clients during external audits by Notified Bodies, FDA, or other authorities.

Yes. Our consultants can help investigate root causes, develop robust CAPA responses, and revise documentation as needed to close non-conformities effectively.

Our team consists of highly experienced consultants, many of whom have worked in industry roles and with regulatory authorities. We bring hands-on knowledge and strategic insight.

Yes, we can manage entire regulatory projects or support specific deliverables, depending on your internal resources and needs.

Yes, we tailor our support for companies of all sizes — from early-stage start-ups navigating their first submission, to large multinationals maintaining global compliance.

You can contact us to schedule an initial consultation. We’ll assess your needs and provide a tailored proposal for how we can support your regulatory goals.

Our Trusted Partners

Reach out to us

Fill in the form below to get in touch and we will get back to you as soon as possible.