How does medical device manufacturing work? When you think of manufacturing, you often conjure images of machines that automatically pick and place parts or production workers assembling or inspecting parts.
But meeting the high quality standards required for medical device manufacturing requires much more. Manufacturing is teamwork!
The experts in the team work hand in hand to ensure that the production line can be installed and operated according to the applicable quality standards (e.g. ISO 13485).
What roles and competencies are required for medical device manufacturing?
- Production workers
- Process technologist
- Validation Officer
- Statistics expert
- Measuring equipment representative
- ESD Officer
- Quality Manager
- Logistics
The order does not represent a prioritization. The key to success is bringing the necessary skills into production. This is precisely where many small and medium-sized companies struggle.
A strong partner with expert knowledge in medical device manufacturing can help you exactly here! Benefit from the years of experience of a strong service provider in the medical technology sector and leverage our expertise!
What advantages does an experienced developer bring to medical device manufacturing?
Setting up your own production facility and bringing it to delivery readiness can be characterized by many regulations, process errors and a long history of trial and error.
With MEDtech Ingenieur at your side, you can benefit from our valuable experience in a wide range of ways:
- You benefit from a flexible and fast service provider with standardized processes and state-of-the-art manufacturing technology!
- You are confident and relaxed during audits and approval procedures because production is carried out by experienced experts (process technologists and qualified employees) and reliable processes that comply with all international standards.
- You benefit from the high quality through strict quality controls and independent audits.
- You have full transparency over production (inventory, process monitoring, delivery dates).
- You can scale with us. From small to large quantities, from prototypes to series production, we can support you.
- You will experience excellent customer service throughout the entire collaboration.
- You have full control over costs and experience no surprises.
Would you like our experts to review your production documents? Contact us! You will receive a free, no-obligation Production Ready Report.
In our Production Ready Report, we will go through your production documents with you in a 6-step process:
The Production Ready Report
The Production Ready Report
You will upload your current production documents in encrypted form to our cloud.
This allows us to start a safe, fast and structured analysis – from specifications and test instructions to FMEAs and validation documents.
We will discuss your requirements together.
We clarify any open questions regarding documentation, product status, and the objectives of the Production Ready Report – always in the context of ISO 13485 and regulatory requirements.
Our experts analyze your manufacturing documents.
We check for completeness, traceability, and auditability – with a focus on smooth and compliant production of medical devices.
A detailed report will be prepared for you.
You will receive a clear assessment of production readiness with information on gaps, risks, and next steps – compact, understandable, and compliant with standards.
At the end, you'll receive final feedback from our subject matter experts. You'll also receive recommendations for action and support if needed.
We will discuss the results together and show you how your product can be successfully transferred into production – if you wish, we can also provide further support throughout the process.
Contact us for a free, no-obligation production-ready report or view our full range of services for Production & Manufacturing for medical devices.