In-house production of software medical devices: Play smart, document cleanly

Want to get straight into the game? Then let's go: In-house production is like the moment when you win the ball in midfield and suddenly have a clear run on goal. You set the pace, make the plays and decide for yourself how precise and effective your software medical devices will be.

No long distances, no dependencies – just you, your team and a clear game plan. Safety, effectiveness and reliability are not the boundaries, but the playing field on which you show your skills.

Ready for the first attack? Then let's take a look at the rules and how you can use them to your advantage.

In-house manufacturing instead of the transfer market: your rules of the game

In-house manufacturing means that the medical device is manufactured and used exclusively in your EU-based healthcare facility (Art. 5(5) MDR). No transfer to external organisations, no placing on the market, no industrial series production. The MDR paves the way: the conformity assessment procedure (‘approval procedure’) is no longer required, and a notified body is not necessary. The basic safety and performance requirements in Annex I remain binding.

In short: in-house manufacturing is a home game – your team, your pace, your tactics.

Why in-house manufacturing is now picking up speed

In-house manufacturing can be the free kick in extra time: precise, effective and decisive. You have the chance to turn the game in your favour.

The advantages in a nutshell:

• Tailor-made solutions: Software precisely tailored to your needs, processes and target groups – like a pass directly into the path of your striker.
• Flexibility and sovereignty: React quickly instead of relying on external providers – like a fast counterattack after winning the ball.
• Efficiency: Seamless integration into existing systems – one-touch combination play without losing the ball.
• Less regulatory effort: No CE marking: a free kick without VAR interruption.
• Innovative strength: Put ideas into practice immediately – like a rehearsed set piece that turns the game around.

Why wait for external solutions to fit? With in-house production, you set the pace.

Playing challenges safely

Even though the MDR sets high standards, you are well positioned with a good strategy. Medical software devices in particular need strong cyber protection – like a goalkeeper who catches every ball safely.

Here's what you need for a safe game:

• Avoid ‘placing on the market’: Passing on to third parties can be an own goal. Use the software exclusively within your organisation, otherwise place it on the market with a full conformity procedure.
• Master the regulatory midfield: Documentation, risk management and clinical evaluation are the areas where the game is decided. Clean processes prevent wrong decisions.
• Resources and know-how: Setting up an MDR-compliant QMS requires stamina and training, but those who stick with it will score.
• In-house production is not a sure-fire success, but with a stable defence and clear tactics, it becomes a strong move.

Governance and responsibilities: clear roles, clean moves

In-house production wins with a compact back four: product responsibility, clinical supervision, IT security/data protection and quality management – clear spaces, clear announcements.

Changes go through lean change management with risk checks, approvals and audit trails – a rehearsed play instead of random dribbling. Make success visible with a few KPIs (time to go live, secure releases, clinical benefits) and regular reviews – including coach feedback.

Your roadmap: From planning to operation

Do you want speed, control and quality? Then take charge of the game yourself.

The most important steps:

1. Analysis and planning:

• Purpose: Clearly define the benefits, target group and scenarios.
• Regulatory classification: Clarify whether the software is a medical device so that you don't end up in the wrong league.
• Carry out risk classification and record the reasons in a comprehensible manner – like the line-up before kick-off: every position has its reason.
• Establish a QMS in accordance with ISO 13485.
• Prepare communication with the authorities – like the match plan for the media: short, precise, without excuses.

2. Development and documentation:

• Software development in accordance with IEC 62304.
• Risk management according to ISO 14971.
• Prepare clinical evaluation.
• Complete technical documentation.
• Make declaration of in-house production publicly available.
• Prove that no equivalent market alternative is suitable – otherwise it's offside.

3. Implementation and training:

• Ensure IT security and data protection – the back four are in place, the centre is tight: no one can get through.
• Train teams in a targeted manner – like practising penalties: confident, repeatable, in.

4. Operation and monitoring:

• Actively implement Corrective and Preventive Action (CAPA) and Post Market Surveillance (PMS): feedback, incidents, improvements.

In short: plan with structure, develop with system, operate with certainty.

Conclusion: clear game plan, strong coach, confident victory

In-house production of medical devices is challenging, and that is precisely where its particular strength lies. What many people don't know is that facilities that set up in-house production properly not only gain flexibility, but also build up internal know-how that becomes a real competitive advantage in the long term. Because every experience, every audit, every optimisation stays in-house – like a training camp from which you return stronger than before.

With the right tactics, a reliable QMS and structured documentation, you can dominate the playing field confidently and effectively.

And this is where adesso comes in: we are more than just a co-coach. We are your strategic partner who knows the playing field, understands the rules and strengthens the team. With a practical approach, audit-proof processes and a deep understanding of regulations, we accompany you from the initial concept through development to go-live. Together, we ensure that you not only play by the rules, but also dictate the match.