Sustainable medical device development

The healthcare market is under immense pressure to be efficient and innovative. In addition, ever stricter legal requirements apply. One possible answer is the digitalisation and networking of medical devices with their existing medical environment. This applies to the exchange of data for treatment, care and diagnosis as well as with the administration.
Medical devices with a high software content are already the order of the day. A clearly defined product vision, clean implementation and documentation of the development in accordance with the approval are indispensable prerequisites to survive in the highly regulated medical environment.

In medical technology, PTA essentially addresses four areas:

  • We support you in the development of product ideas and help you implement them.
  • We make your medical devices fit for the digital era and ensure that they comply with legal requirements regarding software and documentation, and are ourselves ISO 13485 certified.
  • We integrate your medical devices into existing healthcare ecosystems, also thanks to our experience from more than 400 interface projects.
  • We support and develop software within the framework of ISO 62304 over the entire life cycle, including maintenance.

Industry challenges and use cases for a successful digital transformation

The development and operation of complex networked medical technology requires a wide range of know-how and a view of the whole. Especially the integration of medical devices into the complex laboratory IT infrastructure requires many years of professional and IT experience.

Precise implementation

Outsourcing of product lines

Regulatory expertise

Technical, IT and methodological know-how

Unsere Kompetenzen in der Medizintechnik

Product Definition Team (PDT)

Together with our customers we develop a common vision of new, promising products. With our unique range of services, we support you from the product idea to the product vision: The targeted product realisation begins with the detailed and sustainable definition of a planned product (product definition). This ranges from scoping to the complete requirements documentation, which includes the identification of the relevant topics with responsible contact persons as well as the elaboration and communication of the core functionalities to all internal and external participants (stakeholders).

In the next step, the product specification is developed by means of requirement engineering. With the help of business analyses we compare the specifications with the market requirements and thus check whether the planned product can survive in the market. Based on the available analyses and specifications, we develop the system architecture and check the usability using modern user experience methods. Finally, our development team carries out the technical evaluation and elaborates implementation concepts. In this way, we accompany our customers from the product vision through the definition to the market-ready product!

Quality and risk management

Manufacturers of medical devices that contain or consist entirely of software have to cope with many and constantly changing regulatory requirements for quality and risk management QM/RM. The certification according to ISO 13485 allows us to establish a quality management system that complies with European and US-American guidelines (FDA, 21 CFR part 820). This also applies to the software development process we use (IEC 62304) and the risk management for medical devices (ISO 14971). Furthermore, we support you in the evaluation of usability (IEC 62366) in order to minimise risks due to lack of usability, e.g. due to incorrect operation. Furthermore, we help you to comply with the following regulations:

– European In Vitro Diagnostica Medical Device Regulation (IVDR) as well as the GxP standards, including CAPA, the corrective and preventive action

– Introduction of documentation regulations for the traceability of reagent and QC data according to the guideline of the German Medical Association (RiLiBÄK 2008) for quality control and quality assurance of laboratory medical examinations.

Take the step with us into the digital future.

Do you have questions, suggestions or are you interested in our offer? We will be pleased to contact you.