THE CHALLENGE

The barriers to the market introduction of devices in the healthcare sector are generally very high and pose major challenges for manufacturers and distributors. Since the introduction of the new European Medical Devices Regulation (MDR) in May 2017, the requirements for the clinical evaluation and classification of medical devices have become significantly stricter. This creates many new requirements, which have to be taken into consideration by the manufacturers. If you do not know all the regulations, or if you do not know how to implement them, the worst case scenario is the failure of the authorisation.

Don’t let it get so far and inform yourself.

We will help you

REFERENCES

With over 1000 person years of project experience in the regulated CE & FDA environment and 800 medical technology customers, we are the most experienced team of experts for the development of medical devices and medical software in Europe. Benefit from our know-how and give us the opportunity to discuss your project idea and identify possible pitfalls in a free confidential consultation. Tell us your vision and we will tell you how it can become a product.

MEDICAL PROJECT CHECKLISTE

Use our Medical Project Checklist to get an overview of the development and revision of your medical device by answering questions. The checklist guides you in a structured way through the following areas:

  • Device incl. classification
  • Hardware and embedded software
  • Digitization, software, apps and algorithms
  • Usability and user interface design
  • Product Design

We will be happy to send you our checklist for free. Please use our contact form.

ABOUT US

We are convinced that only excellent medical devices can achieve excellent success in marketing and use. At Medical Device Experts – founded out of four highly specialized companies – we are on hand as general contractors to give each ambitious customer the ability to develop first-class medical devices and launch them on the market quickly and safely. We are at your service – from the initial idea and seamless certification, to reliable production and post-market surveillance. One schedule, one contact partner, one goal. No ifs, no buts.

We are the medical device experts, a team of the four companies Mechatronic AG, BAYOOMED, Custom Interactions GmbH and Puls Produktdesign. At our location in Darmstadt we offer you many years of experience in the following areas:

  • Design of medical devices
  • Development of embedded software for medical devices
  • Development of software for extern devices and medical apps
  • Usability tests and interface design
  • Product Design

Without difficult arrangements between various partners. Without tedious travel.
With an innovative approach to the development of medical devices.

QUESTIONS?

Do you have any questions? Need support? Do you want reliable partners for a successful development? Get to know us!

We are looking forward to seeing you!

Giuseppina Falcone

Giuseppina Falcone

Embedded Software and Medical Devices
Benjamin Franz

Benjamin Franz

Usability-Testing and Interface Design
Miriam Schulze

Miriam Schulze

Development of Medical Software and Mobile Medical Apps
Dieter Fornoff

Dieter Fornoff

Product Design

Meet us at MEDICA / Compamed from 18. to 21. November

Visit us at Medica, the world’s leading trade fair for the medical industry or at Compamed, the leading international marketplace for medical suppliers and product development. At the booths at Medica (13 D80) and Compamed (8b H03) you can inform yourself about the cooperation of the four companies.

13 / D80

 BAYOOMED Medical Software / Custom Medical

8b / H03

 Mechatronic AG / Puls Produktdesign

If you are interested in free tickets, please feel free to write to medica@medical-device.expert