Product Development

We help our clients take an interesting and promising technology from the lab to a successful commercial product launch. We combine our experience in working in a highly regulated environment with in-depth knowledge of building safe, effective and secure technologies.

Either working with your in-house team, or outsource partners, we bring a wealth of expertise combined with a high-energy approach to professional product development.

Our approach to project management provides clarity on resources that are required, direction to team members and visibility of progress. We can work in both traditional and agile methodologies to deliver products that customers want, timely regulatory clearance or approval and profitable business models.

Regulatory Consulting

A good regulatory plan can mean faster time to market and for less cost. An in-depth understanding of the regulation in key markets enables us to help our clients avoid costly delays and rework. We have extensive knowledge of and hands-on experience in EU MDR and IVDR, US FDA regulations and regulation in the rest of the world.

We have helped our clients build successful applications for approvals and clearances in the UK, EU, US, Australia/NZ, Canada, China, India and other territories. We can assist by providing guidance and submission reviews. We can also take on the full task of building Technical Documentation and handling the submission process liaising with Notified Bodies and regulators.

Management Systems

We take an integrated approach to building management systems for our clients. This enables us to help them achieve the certifications that they need for ISO 13485 (Quality Management), ISO 270001 (Information Security) and ISO 14001 (Environmental Management).

We have a deep understanding and extensive experience in building efficient and compliant bespoke procedures for risk management (ISO 14971), Health Software Development (IEC 82304), Medical Device Software (IEC 62304) and Usability Engineering (IEC62366).

Risk Management

We are specialists in all areas of risk management. We can help our clients by building a Risk Management Process and providing template documents to meet regulatory requirements and ISO14971. Furthermore we can provide expert resources to create risk management plans, conduct risk analyses using a variety of techniques such as hazard analysis, fault tree analysis, failure modes and effects analyses, etc. We have in-depth knowledge and practical experience of safety critical systems and software development and are well placed to support development of effective risk control measures. We can also support clinical benefit evaluations and write the risk management report.

Software Development

We understand the realities of software development in a variety of contexts, from embedded systems where the software is close to the hardware to distributed apps in the cloud. We can help our clients establish pragmatic processes, facilitate development and ensure that software is safe, reliable and robust. We are specialists at adapting agile development processes such as scrum and Kanban to create safety critical software and to comply with regulatory requirements and standards such as IEC 82304 and IEC 62304. We can help build the technical documentation required for regulatory submissions allowing your developers to focus on what they do best.

Clinical Evaluation

We can support medtech businesses with a range of clinical activities. This includes Clinical Evaluation Plans, Clinical Investigation planning and management, Clinical Evaluation Reports, Post Market Clinical Follow-up and Periodic Safety Update Reports.

Our clinical services are closely related with risk management and the evaluation of the benefit-risk ratio.

Training

We can provide bespoke training on a range of topics including developing products in accordance with regulations, specific standards such as ISO 13485, ISO 14971, IEC 82304 and IEC 62304. In addition we can provide training on developing safe software, adopting agile methods in safety critical systems and building secure software systems.