Medical Devices

Medical Device Regulatory Consultancy

We specialise in the field of medical device regulatory affairs including complex, class III devices and software (SAMD) and is built on years of experience in this field, covering Europe, the US, UK and other regions. 

Our work spans the Life-Cycle (figure 1) from Planning, through Development and Data Generation, Regulatory Clearance, Expanding Territories and finally Maintaining Approval, while protecting reputation.

Medical Device Strategy and Planning

The crucial starting point, key for business planning and invaluable for board-level or investor confidence. For details on how we approach this, see our Strategy page.

Device Development

There are set or expected standards and methods for development work to submit to regulators. We are experienced in the specific standards and requirements for risk management, biological evaluation, clinical evaluation and others. These are fleshed out in our Development Page.

Approve: Submission and communication with Regulatory Authorities

We are experienced in assembling submissions and handling the correspondence with regulatory bodies, for FDA, CE, UKCA and others. We work on US FDA submissions including 510(k) notification, more complex PMA and the De Novo route for products with no predicate device. We often find the FDA pre-submission meeting process very useful for clarifying requirements before the submission, avoiding problems later on.

Our CE submissions have also covered classes I to III, including filing for CE mark approval of devices containing a drug component and software as medical device.

Expand - Global Registrations

Regional expansion brings multiple registrations and typically communication with a third party (such as a distributor) and may need translated material. This potential resource drain needs to be handled in an efficient way. We have recent experience working on registrations in Australia, Canada, China, Japan, India, Brazil, across the Middle East and others. We are used to working with in-country representatives to clarify requirements and provide the right information in a timely way.

Sustain - Maintain Product Approvals and Reputation

Modern standards such as Medical Device Regulation (MDR) have significant post-market surveillance and vigilance requirements to maintain product approvals. Changes, such as the MDR transition, create significant added workload to support a company’s current products. We can reduce your workload in areas such as: Post-Market Clinical Follow-up plan (PMCF), post-market surveillance (PMS), complaint monitoring, risk management, clinical evaluation reporting and label updates.