We will be the Legal Manufacturer for your Medical Device Software

Specialised Legal Manufacturer for Medical Software

We assume manufacturer responsibility for your medical device software, medical app or DiGA. This includes ensuring overall regulatory conformity in accordance with MDR, DiGAV and ISO standards as the so-called legal manufacturer of the medical device.

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We become the Legal Manufacturer for your Medical Device Software and/or DiGA

You are able to concentrate on your core competence and retain full control over your product. At the same time, we ensure compliance with the regulatory requirements for your MDR medical device. This means that you do not have to set up a quality management system (QMS) at your company and are not held back by regulations.

Graphic: Distributor service for medical devices and DiGA

Certified according to ISO 13485 and ISO 27001

We maintain an established quality management system for software medical products that is certified in accordance with ISO 13485. At the same time, our company (our ISMS) is also certified in accordance with ISO 27001 for information security. As a medical device manufacturer, we ensure that your company’s and your users’ sensitive data is secure and fully protected.

Specialized Expertise for Software Products

We are a team of 25 regulatory and medical device software experts. We have been developing software as a medical device and DiGA for many years. As a manufacturer of medical devices, we are therefore very familiar with the individual challenges of complex medical software, apps and digital health applications (DiGA).

How we launch your product onto the market efficiently and safely. In the process we accompany and advise you on all relevant topics.

If required, we can also take over the (further) development, operation and technical support for your software.

Your Benefits

Maximum safety for your medical device

Thanks to our many years of experience, we can bring your product to market safely. This eliminates unnecessary regulatory risks for your company.

In-depth consultation for your SaMD

We have been bringing software medical products to the market for our customers for many years. We provide consultation on all topics related to medical device regulation, DiGA, market access, artificial intelligence, sales and much more.

Faster market access

We bring your software to market in a short time. This means you can generate sales earlier and become profitable with the product more quickly.

Concentration on core competence

You can concentrate on your core expertise. You do not have to laboriously build up a QMS and expertise in medical device regulation.

mamly

How we support Mamly
as a Legal Manufacturer

Mamly is a medical device app for the mental health of pregnant women. Find out here how we take on the role of the Legal Manufacturer for this successful product.

View Case study

kontina

How we support Apogepha
as a Legal Manufacturer

kontina is a medical device for treating the symptoms of an overactive bladder (OAB). The app helps users to promote and improve their own bladder health in the long term. Read here how we are taking on the role of the Legal Manufacturer for this successful product.

View Case Study