FAQs

We can work with the majority of medical device manufacturers seeking compliance of their devices in accordance with Medical Device Regulation (EU) 2017/745, including both hardware and software devices. We also offer a free consultation, so please feel confident about discussing your requirements with a member of our team.

Yes. We adhere to the highest standards of professionalism and regard maintaining confidentiality and data security as a cornerstone of our practice. We also comply fully with the requirements of GDPR. Contact us to start your conversation today.

Our medical device regulatory consulting services are built around a strict quality framework and we only work with clients who share this commitment to quality. Our CEO is a medical doctor with years of experience in the medical device industry and assumes personal responsibility for every project. Our product development process integrates client feedback throughout product production, ensuring a constant focus on your needs.

We work with clients of all sizes and at all stages of their regulatory compliance journey. Our team are here to help and are happy to respond to general enquiries, even if you don't feel like you know where to start.

We are experts at 'tuning in' to your requirements and will guide you through the entire process. Our free EU MDR Guidance Resources stand as proof of our commitment to help you understand your obligations under the MDR.

We also offer our Understanding the EU MDR training course, which will allow you to take control of your regulatory strategy and manage it with confidence.

Yes. Software as a Medical Device (SaMD) is an increasingly-important segment of the medical device market. We have extensive experience in building regulatory systems for medical device software and offer a special application of all our MDR services for software products. We also offer unique downloads and White Papers that focus specifically on Software as a Medical Device.

At its core, working with the MDR is about working with clinical evidence. Our international team of medical reviewers are active healthcare clinicians who are experts in their field. They offer an unparalleled ability to critically evaluate the safety and performance of a medical device, with specific insight into how the device directly impacts patient care.

Whether you need to generate clinical evidence for PMCF, analyse data for writing a CER, or get your software application MDR-ready, our medical experts have the medical acumen to ensure that your clinical evidence is produced and interpreted with the highest levels of professionalism. Medical professionals work with clinical evidence all day and we will bring their specialist capabilities directly to your MDR strategy.

Yes. Whilst we don't act as representatives directly, we have a close working relationship with a carefully curated partner that can act as your EU Authorised Representative (EC REP), UK Responsible Person (UKRP) or Swiss Authorised Rep (CH-REP). Please contact us directly for details.

We believe in transparency and aim to build long-term relationships with our clients. This commitment is demonstrated by our customer-focused pricing strategy. You pay a small deposit upfront, only paying the balance when the work has been completed to your total satisfaction. For higher-value projects we offer flexible payment packages on an individual basis — please contact a member of our team to find out more.

Yes. Our unique business model allows us to scale to accommodate almost any amount of work. Many of our medical professionals remain clinically active, meaning that we have trained more than we presently need. This system allows us to have ready availability of redundant capacity that can be called upon in the event of a surge in demand. Whatever your requirements, our unique business model allows us to step in faster than any of our competitors. Please contact us to discuss your requirements.

Yes. Our EU MDR training courses will give you confidence and clarity in driving your MDR strategy yourself. These training courses are complimented by our EU MDR templates, documents & tools, which will help you build your medical device's regulatory file in-house, saving you time and money.

No. We will work with you to produce systems and to support your EU MDR compliance, but we do not conduct research ourselves. We will provide tools for you to conduct your own Post-Market Surveillance. Our range of services are designed to assist you in this matter.