Frequently asked questions
What does inotec FEGmbH do?
We at inotec FEGmbH are a full-service partner based in Leipzig for manufacturers of medical devices, IVDs, SiMDs and SaMDs. For over 30 years, we have been developing and manufacturing medical systems and electronic products for national and international medical device and IoT companies.
Who does inotec FEGmbH work for?
The team develops and manufactures products for local and global medical technology and IoT companies, on behalf of renowned clients.
Is the entire product life cycle supported?
Yes. It is important to us that we oversee the entire process – from the initial idea through development and approval to life-cycle management. In doing so, we handle project organisation, electronics, software, mechanics, AI and quality management.
Do you offer both one-off items and mass production?
Depending on your needs, we can handle everything from very small production runs to large-scale production runs of more than 500,000 units, applying the same quality standards to small and very small production runs as we do to large-scale production runs.
Is the company certified under DIN EN ISO 13485?
Yes, we have a DIN EN ISO 13485-certified quality management system. At the same time, we are in the process of obtaining ISO 27001 certification.
Do you develop medical software and AI applications?
Yes, including AI in SaMD and SiMD. This is done in accordance with certified, verifiable processes that comply with DIN EN 62304.
Is it possible to operate as a legal manufacturer?
Yes. We will place your medical device on the market and assume regulatory responsibility. This can be customised to your specific needs.
Where is inotec FEGmbH headquartered?
Biedermannstraße 9–13, 04277 Leipzig, Germany.
What makes a “legal manufacturer” unique, and when do you need one?
As a legal manufacturer, we place your medical device on the market and assume regulatory responsibility: from technical documentation and conformity assessment to post-market surveillance. This is a good option if your company does not have its own quality management system, for example as a start-up or when expanding into the EU.
Which obligations fall to inotec FEGmbH, and which remain the responsibility of the client?
We provide the certified QMS, the PRRC, the technical documentation, as well as post-market surveillance and vigilance. All provisions are set forth in the contract (OEM/PLM).
Is a separate PRRC required if inotec FEGmbH acts as the legal manufacturer?
No. If inotec FEGmbH acts as the legal manufacturer, we will designate the Person Responsible for Regulatory Compliance (PRRC) under the MDR. In this case, the division of responsibility between the contractor and the client must be clearly defined in the contract.
How long does CE marking of a medical device under the MDR take?
Typically between 12 and 18 months from the start of the approval process. However, this depends on the risk class, the notified body and the available clinical data. For products in a lower risk class, approval is usually faster.
How is the risk class of a medical device determined?
The risk class depends on various factors. The classification rules in Annex VIII of the MDR and the intended use of the product are essential in this regard. The team at inotec FEGmbH provides support with classification and technical documentation.
Does inotec FEGmbH also provide support for in vitro diagnostic medical devices under the IVDR?
Yes. We are also here to assist you with matters related to in vitro diagnostic medical devices (IVD) and, in this context, comply with both the IVDR and the MDR.
What content-related considerations should be taken into account in technical documentation under the MDR?
The following items are mandatory: product description and intended use, risk management, verification and validation documentation, clinical evaluation, and labelling and instructions for use. inotec FEGmbH prepares these documents or assists the client in doing so.
What is the cost range for a medical device during development?
The costs depend on several factors, such as complexity, product class and the scope of approval. A quote is provided following a project inquiry and a feasibility assessment. Please feel free to contact us using the contact form.
Does inotec FEGmbH develop software as a medical device (SaMD) in accordance with IEC 62304?
Yes. We develop software as a medical device (SaMD) through a certified process with complete documentation. This process takes cybersecurity into account in accordance with IEC 81001-5-1.
What is the validation and approval process for AI in a medical device?
AI is evaluated through a certified validation process and subsequently authorised as part of the medical device in accordance with the MDR. Since the EU AI Act must also be complied with in this context, we conduct preliminary tests using large datasets and document the results.
Do you offer to take over an existing product or provide solutions for component obsolescence?
Yes. At inotec FEGmbH, we can take on existing products and revise them (redesign). We also address component obsolescence through component management and, if necessary, assist with recertification.
Can inotec FEGmbH also manufacture prototypes and small production runs, for example, for clinical trials?
Yes. inotec FEGmbH also manufactures prototypes and small production runs for clinical trials. The same quality standards apply here as for large-scale production runs. Quantities range from 1 to over 500,000.
Are devices also serviced abroad?
Yes. We also offer services (maintenance, calibration, repair and refurbishment) for medical devices worldwide. Upon request, we are also happy to provide service level agreements and failure analyses.
Where is the data stored for training AI models?
Data is stored on our own servers in Germany. We strictly comply with the GDPR.
What is the process for collaborating with inotec FEGmbH?
First comes the inquiry, followed by the feasibility study. Next come the proposal and the project kick-off. For each project, there is a designated contact person from the inotec FEGmbH team.
Is collaboration also possible for start-ups and companies that do not produce medical devices?
Yes. inotec FEGmbH is active in a wide range of areas and collaborates with start-ups as well as established companies and industrial and IoT clients outside the medical technology sector.