Every Camgenium development partnership includes structured knowledge transfer. We ensure your engineers understand the platform, the regulatory landscape and the technologies underpinning your device, so that your organisation grows stronger throughout the engagement.
Medical device standards mandate documented competence for every person contributing to your product. Building that capability into a development partnership reduces the overall project timescale.
Clause 6.2 requires organisations to determine the necessary competence for personnel performing work that affects product quality, and to provide training or take other actions to achieve that competence. We provide evidence of training for audit.
Software lifecycle processes must be carried out by personnel with appropriate training and experience. The standard expects that competence is evidenced and that training records are available for audit.
Cybersecurity lifecycle activities require specialist knowledge. Personnel involved in threat modelling, secure design and vulnerability management must demonstrate competence in these disciplines.
Knowledge transfer is built into every development partnership, delivered by the same engineers who are building your product.
Structured sessions at our Cambridge offices where your team works alongside ours on your project. Direct access to demonstration hardware, development environments and the engineers who know your codebase.
Regular sessions via Microsoft Teams where our engineers walk your team through architecture decisions, code reviews and regulatory processes. The same depth of knowledge transfer, without the need to travel.
Your engineers work directly alongside ours on real deliverables. They absorb the knowledge they need through hands-on collaboration, then progressively take ownership as their confidence and capability grow.
Through the course of a development partnership, your team builds practical competence across all the disciplines their product demands. Every area is taught in the context of your specific project and regulatory classification.
Your team develops a thorough grounding in the regulatory landscape for medical device software, learning the standards and the evidence required through direct involvement in your project's compliance activities.
Your engineers build practical cybersecurity competence by participating in threat modelling, secure architecture reviews and vulnerability management activities on your own device, with our specialists guiding the process.
Your team learns medical device software processes by working through them on your project: from requirements capture through architecture, implementation, verification and release, producing the evidence trail that notified bodies expect.
Camgenium is an expert at building SaMD and accessory apps. If you wish to build your own apps, we can train your team to leverage our platform's benefits to achieve certification.
Your team gains practical understanding of the cloud infrastructure supporting your device: provisioning, fleet management, OTA updates, data handling and the regulatory requirements that apply to backend systems.
Quality managers, project managers and operational staff develop practical competence in QMS processes, document control, CAPA and audit preparation through direct involvement in your project's quality activities.
AI tools including Claude, ChatGPT and Copilot are increasingly used in engineering workflows. As part of our development partnerships, we ensure your team understands how to use these tools safely within a regulated medical device environment.
Large language models can accelerate development, but their use in a medical device context demands careful governance. Generated code must be verified, IP must be protected, and QMS procedures must account for AI-assisted contributions.
Our training covers the practical realities: when LLMs add value, where the risks lie, and how to integrate AI tools into your development processes without compromising regulatory compliance or audit readiness.
Knowledge transfer is tailored to your team's existing experience and the specific demands of your project. It begins at project kickoff and continues for the life of the partnership.
At the start of every partnership, we review your team's current competencies against the requirements of your project, your regulatory classification and the standards that apply. This shapes the knowledge transfer plan alongside the development roadmap.
A knowledge transfer programme is designed alongside the development plan. We agree learning objectives, assign engineering pairs and schedule structured sessions around project milestones.
Knowledge transfer happens through collaborative development, structured sessions and paired engineering. Everything is specific to your project; your team learns by building their own product.
Competence is assessed and documented. Training records, competence matrices and evidence of capability are produced in formats compatible with your quality management system.
Capability building does not end at product launch. As your long-term partner, we remain available to support your team as they encounter new challenges, technology changes or evolving regulatory requirements.
The engineers who transfer knowledge to your team are the same people building your product: practising engineers and regulatory professionals with direct, current experience.
Knowledge transfer is included in every Camgenium development partnership. If you are building a connected medical device and want a partner who invests in your team as well as your product, we would welcome the conversation.