Get in touch!
Do you have a question for our technical experts? Or are you interested in learning more about our services and solutions? Please send us a message, and a member of our team will get back to you as soon as possible.
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.
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.
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.
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.
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 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.
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.
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 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Sumi Thaker, CEO, Momentum Bioscience Ltd
Craig Marshall, CEO, OrganOx Limited
Alec Mills, Co-founder, DAME
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.