Product Development
From an initial concept to readiness for clinical investigation
Developing a medical device requires a coordinated approach to its intended use, technical performance, safety and the evidence needed to support further development. We help medical device companies and start-ups translate their ideas into a practical development plan, identify gaps and organise the expertise and testing required at each stage.
Our support is tailored to the maturity of your product and the capabilities of your team. We can assist with an early concept, review an existing development programme or help resolve specific challenges before progressing towards clinical investigation.
Development strategy and planning
We help clarify the intended purpose of the device, its target users and the clinical need it is designed to address. We work with your team to define development objectives, key milestones and the evidence needed to support decisions along the way.
The resulting plan connects technical activities, testing and clinical preparation, with realistic timelines, responsibilities and resource requirements.
Technical and engineering support
We provide advice on design, materials, manufacturing considerations and the relationship between product characteristics and expected performance. We help identify technical uncertainties and areas requiring further investigation before the design progresses.
Where a project requires additional specialist expertise, we can involve experts selected for the particular technology and development challenge.
Risk management support
We help teams identify and assess risks associated with the device, its intended use and reasonably foreseeable misuse. We support the connection between identified risks, design decisions, risk control measures and the activities needed to evaluate their effectiveness.
Our approach helps make risk management a practical part of development and a source of input for testing and clinical planning.
Preclinical testing and laboratory coordination
We help define the scope and sequence of preclinical testing appropriate to the device, its materials, intended use and stage of development. Through partner laboratories, we can arrange access to relevant testing capabilities and support coordination between your team, technical experts and testing providers.
We assist with the preparation of testing requirements, review of laboratory proposals and interpretation of findings in the context of the development programme.
Verification, validation and technical documentation
We support the planning of activities needed to demonstrate that the device meets its design requirements and is suitable for its intended use. We help organise technical evidence, review documentation for consistency and identify gaps that may require additional testing or clarification.
Our involvement can include reviewing the relationship between product specifications, test results, risk management records and the information supplied with the device.
Preparation for clinical investigation
We help assess whether the available technical and preclinical evidence supports progression towards clinical investigation. We identify outstanding questions, activities and documentation needs, and coordinate input from technical, clinical and regulatory specialists.
This provides a structured transition from product development to clinical planning, with a clear understanding of what is ready and what still needs to be addressed.
A development plan built around your product
Our support can cover a defined technical task or coordination across several stages of development. We agree the scope, responsibilities and deliverables with your team, bringing together the expertise and laboratory resources needed to move the project forward.
Clinical Investigation
From clinical questions to a well-planned investigation
A clinical investigation should generate meaningful evidence about a medical device while remaining feasible for investigators, participants and the sponsor. We help medical device companies translate their development objectives into a clinical investigation plan and organise the activities needed to deliver it.
Our support covers both new investigations and ongoing projects. We combine clinical, technical and operational expertise to address the specific characteristics of the device, its intended use and the experience of the sponsor’s team.
Clinical investigation strategy
We review the intended purpose of the device, existing evidence and the clinical questions that remain unanswered. We help define the objectives of the investigation and its role within the wider development programme.
We advise on the appropriate study approach, target population, endpoints and follow-up, taking account of the device’s characteristics, anticipated benefits and risks, and practical conditions of use.
Investigation design and documentation
We support the preparation and review of clinical investigation plans, study synopses, investigator-facing documentation and participant information and consent materials. We help align eligibility criteria, study procedures, assessments and visit schedules with the investigation’s objectives.
Our approach balances the evidence needed with participant burden, site capabilities and the practical demands of using the device in a clinical setting.
Sponsor readiness and submission support
We help companies establish the responsibilities, processes and resources needed to sponsor a clinical investigation. This includes planning oversight, organising documentation and identifying activities that require external support.
We assist with the preparation and coordination of application materials for the relevant authorities and ethics committees, working with legal and regulatory specialists where needed. We also support responses to questions and the coordination of updates during the assessment process.
Site selection and investigation start-up
We support the identification and assessment of investigators, research sites and service providers. Feasibility reviews consider access to the intended population, relevant clinical experience, equipment, staffing and the ability to perform device-specific procedures.
We help coordinate start-up activities, including site preparation, training requirements and arrangements for device supply, storage, accountability and use. Where appropriate, selected investigations may be considered at the associated Medicome research site, subject to feasibility, resources and sponsor selection.
Investigation oversight and medical support
During an investigation, we help sponsors maintain oversight of progress, site activities and delegated responsibilities. We support communication between the sponsor, investigators and providers, review emerging operational issues and coordinate agreed actions.
Our physicians can provide medical monitoring and clinical input within a defined scope, including support with eligibility questions, protocol-related medical issues and the review of emerging clinical information.
Managing changes and completing the investigation
We help assess and coordinate amendments, address recruitment or delivery difficulties and update investigation documentation as the project evolves. We support the review and escalation of safety-related information and device deficiencies within agreed responsibilities and reporting processes.
As the investigation approaches completion, we assist with planning outstanding activities, coordinating contributions from sites and providers, and preparing or reviewing the clinical investigation report.
Support matched to your investigation
We can help prepare a new investigation, strengthen an existing sponsor team or provide focused assistance at a critical stage. The scope of our involvement is agreed around your device, study objectives and available resources, with clear deliverables and communication arrangements.
Audit & Quality
Build reliable processes. Strengthen confidence in your development
Medical device development requires a quality system that connects everyday activities with product safety, performance and reliable documentation. We help medical device companies and start-ups establish practical processes, assess existing arrangements and address gaps as their organisations and products develop.
Our support covers ISO 13485 implementation, development-related quality processes and audits of clinical investigation activities. Each assignment is tailored to the company’s role, product portfolio, development stage and available resources.
ISO 13485 implementation
We help companies plan and implement a quality management system aligned with ISO 13485. We begin by assessing existing practices, identifying gaps and defining the processes and responsibilities needed within the agreed scope.
Our support includes developing documentation, introducing procedures, preparing staff and helping the organisation put the system into everyday use. For companies seeking certification, we can support preparation for an independent certification assessment.
Design and development processes
We help teams establish a structured approach to design and development, with clear inputs, outputs, reviews and decision points. We support the connection between design activities, risk management, verification, validation and the evidence recorded in technical documentation.
We also help define how design changes are assessed, approved and documented, so that their implications for testing, clinical activities and existing evidence are considered.
Supplier and outsourced activity controls
Medical device projects often depend on external designers, manufacturers, laboratories and other specialist providers. We help companies establish proportionate processes for selecting, evaluating and overseeing these partners.
Our support includes defining quality requirements, clarifying responsibilities, reviewing supplier documentation and planning how outsourced activities and deliverables will be assessed.
Quality system reviews and internal audits
We assess whether documented procedures reflect actual working practices and whether the organisation can demonstrate that its processes are being followed. Reviews may focus on a specific activity or cover a broader part of the quality management system.
We help identify weaknesses, inconsistencies and missing evidence, with findings and recommendations prioritised according to their significance for the product and the organisation.
Clinical investigation audits
We audit selected sponsor, provider and research site activities associated with medical device clinical investigations. Depending on the scope, this may include informed consent, eligibility assessment, adherence to the clinical investigation plan, source documentation, device accountability, staff training and oversight.
We can also assess the processes used to identify, document and escalate safety-related information and device deficiencies, including communication between investigators and the sponsor.
Corrective actions, training and assessment readiness
We support root cause analysis and the development of corrective and preventive action plans. We help define responsibilities, deadlines, evidence of completion and methods for checking whether the actions have been effective.
We also provide procedure-based training and readiness reviews before certification assessments, external audits or inspections. The emphasis is on clear responsibilities, accessible records and processes that staff understand and can apply consistently.
Quality support that works in practice
Our aim is to help you establish a quality system that is proportionate to your activities and supports the development of your organisation. We can assist with implementation, provide an independent assessment or support agreed improvements following identified findings.
Where consulting and audit services are combined, we define arrangements to manage conflicts of interest and preserve the independence of the assessment, including separate reviewers where appropriate. Certification decisions remain with the independent certification body.
Legal Support
Legal clarity throughout medical device development
Medical device projects bring together developers, manufacturers, clinical investigators, laboratories and other specialist partners. We help companies establish clear agreements and address the legal questions that arise during product development, clinical investigation and collaboration with external providers.
Legal services are provided by our collaborating legal counsel and law firm, working alongside our technical and clinical experts. This coordinated approach helps ensure that legal advice reflects the device, the stage of development and the practical requirements of the project.
Regulatory and local legal advice
We provide legal advice on the EU Medical Device Regulation and applicable national requirements relevant to the planned activities. We help companies understand their responsibilities and assess the legal implications of development arrangements, clinical investigations and cooperation with other organisations.
Where a project involves several countries, we help identify matters requiring jurisdiction-specific advice and coordinate input from local counsel where needed.
Development and collaboration agreements
We support the drafting, review and negotiation of agreements with development partners, technical consultants, research organisations and manufacturers. We help define the scope of cooperation, responsibilities, deliverables, acceptance criteria and arrangements for changes or early termination.
Our review also addresses ownership of development results, access to technical information and the rights needed to continue the project as partnerships evolve.
Clinical investigation agreements
We prepare and negotiate agreements between sponsors, research sites, investigators and providers involved in medical device clinical investigations. We help align contractual responsibilities with the clinical investigation plan and the intended organisation of the study.
Key areas include payment terms, device supply and accountability, training, documentation, safety-related communication, liability, insurance provisions and arrangements for study completion or termination.
Laboratory and service provider contracts
We review agreements for preclinical testing, technical assessments and other outsourced activities. We help clarify testing requirements, timelines, reporting obligations, access to results and the handling of incomplete or disputed deliverables.
We also support international negotiations, including the review of governing law, dispute resolution provisions and contractual arrangements between partners operating in different jurisdictions.
Confidentiality, intellectual property and data
We help protect confidential information exchanged during discussions with potential partners, providers and research sites. We prepare and review confidentiality agreements and contractual provisions concerning background knowledge, newly developed intellectual property and publication rights.
We also advise on contractual arrangements for access to and use of project data, including personal data protection responsibilities where relevant to the planned activities.
EU legal representation for clinical investigation sponsors
Through our collaborating law firm, we offer EU legal representation for sponsors established outside the EU where required for a medical device clinical investigation. The applicable requirements, responsibilities and communication arrangements are assessed for the project and defined in a separate agreement with the law firm.
This service concerns the sponsor’s clinical investigation responsibilities. It is distinct from the role of an authorised representative acting for a non-EU medical device manufacturer.
Legal support matched to your project
Our involvement can cover a single agreement, a defined negotiation or continuing advice throughout development and clinical investigation. We also assist with amendments, changes in scope and disagreements between project partners.
We agree the scope of legal support at the outset and coordinate it with the technical and clinical work, helping your team make informed decisions and maintain clear responsibilities as the project progresses.
