Medical Device Regulatory Consulting

We accelerate regulatory approval and market introduction.

Our regulatory consulting services help you navigate the regulatory landscape and accelerate approval and market access for medical devices and IVDs.


  • CE/UKCA Mark Certification
  • FDA approval (510(k), PMA and De-Novo)
  • NMPA/CFDA submissions
  • NRTL Accreditation (UL/ETL/MET)
  • Risk Management (ISO 14971)
  • Medical Device Software Development (IEC 62304)
  • Usability Studies (IEC 62366)
  • Safety & EMC testing (IEC 60601/61010/61326)
  • Technical File Audit & Gap Analysis
  • Design Transfer (pFMEA/Process Validation)

Helping secure the future of your medical device

We provide expert medical device regulatory consulting for every step of the product development lifecycle. Our global regulatory affairs team has decades of experience working with medical devices and in-vitro diagnostics of all classes and can help you gain access to European, North American, and Asian markets with speed and efficiency.

Startups and world-leading OEMs choose to partner with us for medical device regulatory consulting because of our knowledge, resources, certifications, and experience bringing compliant medical devices to market.

Our Capabilities

CE/UKCA Mark Certification

Achieving and maintaining CE Mark certification can be a complex process, but our experienced team can provide support at every stage, including Notified Body selection, device classification, performance evaluation, process validation, and preparation of all technical documentation.

FDA approval (510(k), PMA, and De-Novo)

As an FDA-registered medical device design manufacturer, we have considerable experience supporting customers with FDA pre-market approval (PMA) and 510(k) applications, and de novo classification requests for US market access.

NMPA/CFDA submissions

If you are thinking about entering the Chinese market for the first time, trying to understand regulatory requirements can be overwhelming, and the system can be difficult to navigate. We’ll help you to understand the requirements before you begin the registration process. With in-country representation for medical devices, we have hands-on experience supporting customers with NMPA/CFDA approvals and have established strong partnerships with Clinical Research Organizations.

NRTL Accreditation (UL/ETL/MET)

To distribute medical, diagnostic, or scientific devices in North America and Canada, you will require NRTL (Nationally Recognized Testing Laboratory) accreditation. We have a successful track record designing devices to meet the requirements, supporting customers throughout the accreditation process, including facility inspections.

Risk Management (ISO 14971)

Risk management is an integral part of medical device development and applies to every phase of the development lifecycle. We incorporate EN ISO 14971 requirements into our quality management system to provide a rigorous, risk-based approach to design and manufacturing while effectively demonstrating compliance within the scope of a project.

Medical Device Software Development (IEC 62304)

Our software design lifecycle is centered around IEC 62304 – the international standard for medical device software development. We can provide technical support and perform a gap analysis for all classes of embedded software and firmware.

Usability Studies (IEC 62366)

IEC 62366 is the international standard for medical device usability analysis and development. Usability is an integral part of the development process because it ensures the safe and effective use of medical devices. We integrate usability engineering throughout design and development and can support usability testing for your device.

Safety & EMC testing (IEC 60601/61010/61326)

Safety and EMC (Electromagnetic Compatibility) has to be demonstrated for all electronic equipment and is an essential part of the CE marking process. We have a proven track record in delivering medical devices, in vitro diagnostic devices, and laboratory instruments that meet IEC 60601 and IEC 61010/IEC 61326 standards.

Technical File Audit & Gap Analysis

To market and sell a medical device in Europe, it will most likely need to bear the CE mark. Our experienced team can help you gain approval from your selected Notified Body by conducting a comprehensive technical file assessment to ensure all evidence is compliant with the regulatory requirements. We can also perform an independent gap analysis of your technical documentation, procedures, and processes to understand what steps you must follow to meet global regulatory requirements.

Design Transfer (pFMEA/Process Validation)

Regardless of whether your device is designed by a third-party design consultancy or by us, we have established procedures and considerable experience in transferring medical devices into manufacture. We perform pFMEA (process Failure Mode Effect Analysis) and Process Validation as part of the Design Transfer to ensure that your device can be manufactured repeatedly and effectively within our established processes. This process is typically performed collaboratively with our customers, as the resulting documentation is often required to support regulatory submissions.

Our Process

Stage 1: Project Planning

Taking the time to understand your idea, determine the scope of work, and create a comprehensive project plan.

All successful projects start with a great plan. Together with your team, our engineers will formulate a detailed project plan outlining the most effective route forward for your device. The plan is treated as a living document and is modified and updated where needed to keep your project on track and ensure we meet your expectations every time.

Stage 2: Concept Definition & Feasibility

Generate early design concepts and proof of principle prototypes to help identify key risk areas and establish feasibility.

With a comprehensive plan in place, it’s time to start bringing your idea to life. From user experience to industrial design and systems architecture, our concept development phase saves you time and money. Our engineers will examine the basic principles of your idea, the technology, and the regulatory requirements and generate concept designs that are not only aesthetically pleasing but satisfy the required functionality and add demonstratable value.

Stage 3: Design & Engineering

Refine the design and develop 3D CAD models and detailed drawings ready for pilot production prototyping and testing. 

With a strong understanding of user needs and a feasible concept agreed, our skilled designers and engineers will further refine the design, creating 3D CAD models and proof of principle prototypes to test and evaluate device performance and ensure it meets specification. It’s the real “nuts and bolts” of the development process, from mechanical, electronics, and systems engineering, to software and firmware development; this is where your device begins to take true form.

Stage 4: Prototyping & Verification

Conduct verification testing on alpha prototypes to ensure your device consistently meets the specification, user needs, and intended use.

It’s time to transform the CAD model into a functional, tangible device. Utilizing prototyping methods, including 3D printing, rapid molding, and laser sintering, we can deliver small batches of alpha and beta prototypes for validation and verification, testing, and regulatory submission. At the end of this stage, your device is ready for transfer to manufacturing.

Stage 5: Pilot Production

Generate detailed works instructions, set up the production work-cell, validate assembly processes, and complete technical documentation and regulatory submissions.

Our in-house Production Engineering team is responsible for the design transfer, from creating detailed work instructions and work-cell set up to process validation and operator training, ensuring a seamless transition from design and development to volume manufacturing. Even if your device is designed by a third-party, we can still support you with new product introduction.

Stage 6: Volume Manufacturing

Full-scale manufacturing, sustaining engineering, and risk management of your device within an ISO 13485 and FDA GMP accredited environment.

As an ISO-certified and FDA cGMP compliant medical device manufacturer, our customers have access to skilled technicians and resources throughout our global manufacturing sites. Your device will be assembled, tested, and packed within a dedicated, project-specific work cell, each with its own operators, work instructions, tools, jigs, fixtures, and testing areas. Our rigorous process controls and quality inspection methods ensure we deliver safe, reliable medical devices on-time and to specification.

Our results speak for

From world-leading OEMs to small, one-person startups, we are proud to have partnered with some of the most recognized names in the MedTech industry to bring to life cutting-edge medical devices that enhance and improve the lives of patients worldwide. 


Our commitment to exceeding customer expectations for quality, delivery, and service has earned us our reputation as one of the most progressive and trusted medical device design and manufacturing partners. But don’t just take our word for it. Discover why 90% of our customers choose to partner with us time and time again.

Some clients we've helped


What our clients say

"ITL has been a trusted partner on two projects for Momentum. Their expertise in diagnostic instrumentation and project management helped us answer complex technical questions about how to automate new disruptive clinical diagnostic testing. The team is very responsive, able to move on ideas and new challenges quickly and deliver against expectations. A pleasure to work with."

Sumi Thaker, CEO, Momentum Bioscience Ltd

"I can strongly recommend ITL as an experienced development partner while also operating as a skilled and reliable manufacturer. It is this combination of skills that underpins ITL’s value proposition to MedTech businesses such as OrganOx. ITL is an excellent fit with OrganOx given their track record of successfully bringing medical devices to market, coupled with its UK headquarters and a US presence."

Craig Marshall, CEO, OrganOx Limited

"We came to ITL with a clear vision and a very basic prototype. While we knew what we wanted, it was clear we were going to need help to bring our idea to life. There were distinct requirements of the device and, after a reassuring first meeting, it was clear ITL understood the challenges. The friendly - and most importantly - plain-speaking team explained their decisions at every stage so we always felt included in the design process."

Alec Mills, Co-founder, DAME

Discover how we can support your next medical innovation

Whether you’re looking to develop an idea or concept into a commercially viable product, or you need help progressing one specific stage of your project, we can help.

Other Services

Concept Development

Design & Engineering

Contract Manufacturing